gmp_catalog_2001[1].pdf

The GMP Labeling SystemFounded in 1987, GMP Labeling serves companies that are regulated by the FDA and/or are registeredfor ISO 9000 standards. Today the GMP Labeling System is used daily in more than 5000 facilities in theU.S., Canada and Europe.

The GMP Labeling System offers labels, signs and software that make it easier to comply with GMPregulations and ISO 9000 requirements as well as demonstrating commitment to compliance. GMPLabeling products help you identify components, pilot batches, raw materials, in-process materials, andareas in your laboratory and in production. GMP Labeling System products are designed in distinctiveshapes, sizes, colors and color-coded titles to prevent lost identities, mix-ups and errors.

Prompt, Courteous ServiceCall or fax your order today and well ship today! Stock items shipped 2nd day guaranteed delivery inthe United States. Custom-designed labels can be printed and shipped within 48 hours.

The GMP GuaranteeYou can return anything, any time, right down to the last label on the roll. No discussions, no problems.You must be completely happy!

Sincerely,

Jon NickersonChief Executive Officer

Bill SayrePresident

STANDARD ROLL LABELS Pages 3-7Quality Control (Q series) 3Status (S series) 4-5Caution (C series) 6Waste (W series) 6Materials (M series) 7

COMPUTER-PRINT LABELS Pages 8-9Pin-feed labels (PF series and CP series) 8Sheet-feed labels (LP series) 9

DESIGN-YOUR-OWN LABELS Pages 10-13How to design your own labels 10Examples of customer-designed labels 12-13

CREATE-YOUR-OWN LABELS Pages 14-15GMPrintsoftware to design and print labels 14

LABEL DISPENSERS Page 21

STANDARD and CUSTOM SIGNS Pages 16-17Standard signs 16How to design your own signs 17

STANDARD OPERATING PROCEDURES Pages 18-19

ORDERING INFORMATION Pages 21-23Design-your-own labels; standard and custom signs; dispensers 21SOPs 21Roll labels 22-23Pin-feed and sheet-feed labels 23

GMP Labeling Inc. 2002

COMPLIANCE REFERENCE BOOKS Back coverReferences for FDA and ISO Compliance

Our labels comply with thecolor coding system of theQuality System Regulations:

Indicates Hold or Not Yet Accepted

Indicates Accepted or Approved

Indicates Rejected, orpotential problem withcomponent or material

To obtain free samples of any of our standard labels just call 800-637-4487Visit our website www.gmplabeling.comRequest free samples and order labels and other products on-line.

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SHEET-FEED: LP SERIES (SEE PAGE 9)

23

ROLL, PIN-FEED, SHEET-FEED LABELS

LABELS10% Disc.2-5 Items

15% Disc.6-11 Items

20% Disc.12-24 Items

25% Disc.25+ Items

UNITPRICE

NO.ROLLCOLORSIZE

CAT.#

MATERIALS: M SERIES (SEE PAGE 7)

QUARANTINE 4" x 2" Red/White 500 S186PF 80.15 72.14 68.13 64.12 60.11QUARANTINE 2" x 2" Red/White 500 S188PF 76.61 68.95 65.12 61.29 57.46IN PROCESS 2" x 2" Green/White 500 S452PF 76.61 68.95 65.12 61.29 57.46RELEASED 2" x 1" Black/Fluor Green 1000 Q006PF 92.43 83.19 78.57 73.94 69.32RELEASED 2" x 2" Black/Fluor Green 500 Q041PF 76.61 68.95 65.12 61.29 57.46APPROVED 2" x 2" Black/Fluor Green 500 Q045PF 76.61 68.95 65.12 61.29 57.46ACCEPTED 2" x 2" Black/Fluor Green 500 Q048PF 76.61 68.95 65.12 61.29 57.46REJECTED 2" x 2" Black/Fluor Red 500 Q057PF 76.61 68.95 65.12 61.29 57.46QC HOLD 2" x 2" Black/Fluor Red 500 Q058PF 76.61 68.95 65.12 61.29 57.46PIN-FEED: CP SERIES (SEE PAGE 8)

PIN-FEED: PF SERIES (SEE PAGE 8)

QUARANTINE 4" x 2" Red/White 500 S186LP 125.65 113.09 106.80 100.52 94.24QUARANTINE 2" x 2" Red/White 1000 S188LP 125.65 113.09 106.80 100.52 94.24QUARANTINE 2" x 1" Black/Yellow 2000 Q007LP 125.65 113.09 106.80 100.52 94.24QUARANTINE 2" x 2" Black/Yellow 1000 Q050LP 125.65 113.09 106.80 100.52 94.24IN PROCESS 2" x 2" Green/White 1000 S452LP 125.65 113.09 106.80 100.52 94.24APPROVED 2" x 1" Black/Fluor Green 2000 Q004LP 125.65 113.09 106.80 100.52 94.24REJECTED 2" x 1" Black/Fluor Red 2000 Q005LP 125.65 113.09 106.80 100.52 94.24RELEASED 2" x 1" Black/Fluor Green 2000 Q006LP 125.65 113.09 106.80 100.52 94.24RELEASED 2" x 2" Black/Fluor Green 1000 Q041LP 125.65 113.09 106.80 100.52 94.24APPROVED 2" x 2" Black/Fluor Green 1000 Q045LP 125.65 113.09 106.80 100.52 94.24REJECTED 2" x 2" Black/Fluor Red 1000 Q057LP 125.65 113.09 106.80 100.52 94.24QC HOLD 2" x 2" Black/Fluor Red 1000 Q058LP 125.65 113.09 106.80 100.52 94.24

WASTE: W SERIES (SEE PAGE 6)SCRAP 4" X 2.5" Black/Yellow 500 W932 81.78 73.60 69.51 65.42 61.34HAZARDOUS WASTE 4" X 2.5" Black/Fluor Red 500 W935 81.78 73.60 69.51 65.42 61.34WASTE FOR DISPOSAL 4" X 2.5" Black/Yellow 500 W936 81.78 73.60 69.51 65.42 61.34

CAUTION: C SERIES (SEE PAGE 6)NOT FOR HUMAN USE* 2" x 0.75" Blue/Yellow 1000 C095 73.15 65.84 62.18 58.52 54.86FOR RESEARCH ONLY* 2" x 0.75" Blue/Yellow 1000 C098 73.15 65.84 62.18 58.52 54.86CAUTION: INVESTIGATIONAL DEVICE* 2" x 0.75" Black/White 1000 C102 73.15 65.84 62.18 58.52 54.86FOR EXPORT ONLY 2" x 1" White/Blue 1000 C114 75.40 67.86 64.09 60.32 56.55FOR REFERENCE ONLY 2" x 1" Red/Yellow 1000 C116 75.40 67.86 64.09 60.32 56.55* Available in smaller size 1" x 0.5" 1000 66.78 60.10 56.76 53.42 50.09

SAMPLE 1.5" x 1.5" Red/Yellow 1000 M023 75.40 67.86 64.09 60.32 56.55SAMPLE 3.0" x 3.0" Red/Yellow 500 M024 83.49 75.14 70.97 66.79 62.62TEST SAMPLE 2" x 1" Red/White 1000 M025 75.40 67.86 64.09 60.32 56.55MATERIAL CONTROL 1.5" Circle Red/Yellow 1000 M032 75.40 67.86 64.09 60.32 56.55INVENTORY 4" x 3.5" Red/Yellow 500 M035 84.67 76.20 71.97 67.74 63.50SAMPLED 2" Oval Red/Yellow 1000 M059 83.04 74.74 70.58 66.43 62.28SAMPLED 3" x 2" Red/Yellow 500 M069 72.90 65.61 61.97 58.32 54.68QA RETAIN SAMPLE 2.5" x 1.5" Red/Yellow 500 M079 65.70 59.13 55.85 52.56 49.28RETURNED GOODS 2" x 3" Red/Yellow 500 M193 72.90 65.61 61.97 58.32 54.68UNIVERSAL-MATERIAL 2" x 3" Red/White 500 M737 72.90 65.61 61.97 58.32 54.68UNIVERSAL-RESEARCH 1.5" x 2.5" Blue/White 500 M792 65.70 59.13 55.85 52.56 49.28UNIVERSAL C-SERIES 2" x 3" Blue/White 500 M793 72.90 65.61 61.97 58.32 54.68QC STABILITY 2" x 2" Blue/White 500 M795 71.80 64.62 61.03 57.44 53.85SOLUTION 2" x 3" Green/White 500 M573R 72.90 65.61 61.97 58.32 54.68BUFFER 2" x 3" Blue/White 500 M213R 72.90 65.61 61.97 58.32 54.68REAGENT 2" x 3" Gray/White 500 M963R 72.90 65.61 61.97 58.32 54.68

QUARANTINE 2" x 2" Red/White 500 S188CP 76.61 68.95 65.12 61.29 57.46IN PROCESS 2" x 2" Green/White 500 S452CP 76.61 68.95 65.12 61.29 57.46APPROVED 2" x 1" Black/Fluor Green 1000 Q004CP 92.43 83.19 78.57 73.94 69.32REJECTED 2" x 1" Black/Fluor Red 1000 Q005CP 92.43 83.19 78.57 73.94 69.32RELEASED 2" x 1" Black/Fluor Green 1000 Q006CP 92.43 83.19 78.57 73.94 69.32RELEASED 2" x 2" Black/Fluor Green 500 Q041CP 76.61 68.95 65.12 61.29 57.46APPROVED 2" x 2" Black/Fluor Green 500 Q045CP 76.61 68.95 65.12 61.29 57.46REJECTED 2" x 2" Black/Fluor Red 500 Q057CP 76.61 68.95 65.12 61.29 57.46QC HOLD 2" x 2" Black/Fluor Red 500 Q058CP 76.61 68.95 65.12 61.29 57.46

Q046

Q045

Q056

Q057

Q005Q004

Q060

Q041

Labels shown actual size. Actual label colors may vary slightly. Red & green labels on this page are fluorescent. 3

ROLL LABELS QUALITY CONTROL (Q series) 800-637-4487

Q006

Q016

Prices on page 22

Q062

Q048

Q008

Q009

Q058

Q007

Q012

Q064

Q065

Q065

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ROLL LABELS

APPROVED 2" x 1" Black/Fluor Green 1000 Q004 75.40 67.86 64.09 60.32 56.55APPROVED 2" x 3" Black/Fluor Green 500 Q045 72.90 65.61 61.97 58.32 54.68APPROVED 4" x 2.5" Black/Fluor Green 500 Q046 81.78 73.60 69.51 65.42 61.34CE 1" x 0.5" Black/Silver 1000 Q016 66.78 60.10 56.76 53.42 50.09RELEASED 2" x 1" Black/Fluor Green 1000 Q006 75.40 67.86 64.09 60.32 56.55RELEASED 2" x 3" Black/Fluor Green 500 Q041 72.90 65.61 61.97 58.32 54.68ACCEPTED 2" x 1" Black/Fluor Green 1000 Q008 75.40 67.86 64.09 60.32 56.55ACCEPTED 2" x 3" Black/Fluor Green 500 Q048 72.90 65.61 61.97 58.32 54.68REJECTED 2" x 1" Black/Fluor Red 1000 Q005 75.40 67.86 64.09 60.32 56.55REJECTED 2" x 1" Black/Yellow 1000 Q009 75.40 67.86 64.09 60.32 56.55REJECTED 4" x 2.5" Black/Fluor Red 500 Q056 81.78 73.60 69.51 65.42 61.34REJECTED 2" x 3" Black/Fluor Red 500 Q057 72.90 65.61 61.97 58.32 54.68QC HOLD 2" x 1" Black/Fluor Red 1000 Q007 75.40 67.86 64.09 60.32 56.55QC HOLD 2" x 3" Black/Fluor Red 500 Q058 72.90 65.61 61.97 58.32 54.68QC HOLD 2" x 3" Black/Yellow 500 Q060 72.90 65.61 61.97 58.32 54.68QC PASSED 1.5" Circle Black/Fluor Green 500 Q065 75.40 67.86 64.09 60.32 56.55HOLD 2" x 1" Black/Yellow 1000 Q012 75.40 67.86 64.09 60.32 56.55HOLD 2" x 3" Black/Yellow 500 Q062 72.90 65.61 61.97 58.32 54.68QUALITY CONTROL 2" x 3" Blue/White 500 Q064 72.90 65.61 61.97 58.32 54.68

QUALITY CONTROL: Q SERIES (SEE PAGE 3)

STATUS: S SERIES (SEE PAGES 4-5)CALIBRATED 1" x 0.5" Black/White 1000 S081 66.78 60.10 56.76 53.42 50.09CALIBRATED 2" x 1" Black/White 1000 S089 75.40 67.86 64.09 60.32 56.55P.M. 2" x 1" Black/White 1000 S202 75.40 67.86 64.09 60.32 56.55CALIBRATION VOID IF SEAL IS BROKEN 0.5" circle Red/Silver 1000 S103 62.18 55.96 52.85 49.74 46.64CALIBRATION VOID IF SEAL IS BROKEN 1" x 0.5" Red/Silver 1000 S104 66.78 60.10 56.76 53.42 50.09VOID IF SEAL IS BROKEN 0.5" circle Red/Silver 1000 S105 62.18 55.96 52.85 49.74 46.64CALIBRATE BEFORE USE 2" x 1" Red/Yellow 1000 S182 75.40 67.86 64.09 60.32 56.55CALIBRATION NOT REQUIRED 2" x 1" Red/White 1000 S183 75.40 67.86 64.09 60.32 56.55DO NOT USE: OUT OF CALIBRATION 2" x 1" Black/Fluor Red 1000 S185 75.40 67.86 64.09 60.32 56.55QUARANTINE 4" x 2.5" Red/White 500 S186 81.78 73.60 69.51 65.42 61.34QUARANTINE 2" x 3" Red/White 500 S187 72.90 65.61 61.97 58.32 54.68QUARANTINE 2.5" x 1.5" Red/White 500 S188 65.70 59.13 55.85 52.56 49.28QUARANTINE 2" x 1" Black+Yellow/White 1000 S189 75.40 67.86 64.09 60.32 56.55QUARANTINE 2" x 1" Red/Yellow 1000 S190 75.40 67.86 64.09 60.32 56.55MRB QUARANTINE 2" x 3" Black/Fluor Red 500 S191 72.90 65.61 61.97 58.32 54.68REWORK REQUIRED 2" x 1" Red/White 1000 S195R 75.40 67.86 64.09 60.32 56.55RETURN TO VENDOR 2" x 1" Red/White 1000 S197R 75.40 67.86 64.09 60.32 56.55PREVENTATIVE MAINTENANCE 2" x 3" Green/White 500 S200 72.90 65.61 61.97 58.32 54.68CONDITIONAL RELEASE 2" x 3" Green/White 500 S201 72.90 65.61 61.97 58.32 54.68DIRTY 1.5" circle Red/White 1000 S314R 75.40 67.86 64.09 60.32 56.55CLEAN 1.5" circle Green/White 1000 S315R 75.40 67.86 64.09 60.32 56.55TO BE CLEANED 2.5" x 1.5" Red/Yellow 500 S316R 65.70 59.13 55.85 52.56 49.28CLEANED 2" x 3" Green/White 500 S318R 72.90 65.61 61.97 58.32 54.68CLEANED 2.5" x 1.5" Green/White 500 S319R 65.70 59.13 55.85 52.56 49.28IN PROCESS 2" x 3" Green/White 500 S451 72.90 65.61 61.97 58.32 54.68IN PROCESS 2.5" x 1.5" Green/White 500 S452 65.70 59.13 55.85 52.56 49.28ON TEST 1.5" x 2.5" Black/Yellow 500 S511R 65.70 59.13 55.85 52.56 49.28STERILIZED 2.5" x 1.5" Blue/White 500 S846R 65.70 59.13 55.85 52.56 49.28DEPYROGENATED 2.5" x 1.5" Red/White 500 S179R 65.70 59.13 55.85 52.56 49.28FILTER CHANGED 2" x 3" Black/White 500 S685 72.90 65.61 61.97 58.32 54.68CAUTION: C SERIES (SEE PAGE 6)NOT FOR CLINICAL USE 2" x 2" Red/White 500 C077 71.80 64.62 61.03 57.44 53.85FREEZE UPON ARRIVAL 3.5"x 1.25" Green/Yellow 1000 C085 82.04 73.84 69.73 65.63 61.53REFRIGERATE UPON ARRIVAL* 3.5" x 1.25" Green/Yellow 1000 C087 82.04 73.84 69.73 65.63 61.53CAUTION: BIOHAZARD* 2" x 0.75" Black/Fluor Red 1000 C088 73.15 65.84 62.18 58.52 54.86BIOHAZARD* 2" x 2" Black/Fluor Red 1000 C118 71.80 64.62 61.03 57.44 53.85STERILE* 2" x 1" Green/Yellow 1000 C090 75.40 67.86 64.09 60.32 56.55CAUTION: NON-STERILE* 2.5" x 1.5" Black/Fluor Red 500 C091 65.70 59.13 55.85 52.56 49.28REFRIGERATE: DO NOT FREEZE* 2" x 0.75" Green/Yellow 1000 C093 73.15 65.84 62.18 58.52 54.86EXPIRATION DATE* 2" x 0.75" Blue/Yellow 1000 C094 73.15 65.84 62.18 58.52 54.86

C SERIES continued on page 23

NEW!

LABELS 10% Disc.2-5 Items15% Disc.6-11 Items


25% Disc.25+ ItemsUNIT

NO.ROLLCOLORSIZE CAT.#


QUANTITY DISCOUNTSFor Design-your-own labels, standard signs,

design-your-own signs and dispensers.Qty. 2-5 = 10%; 6-11 = 15%; 12-24 = 20%; 25+ = 25%.

QUARANTINE

1992 GMP LabelingS187

Mat:

Lot #:

P/N:

Amt:

Pending:

Date: By:

S187S186

S188

S190

S191

Labels shown actual size. R signifies removable adhesive. 4

RETURNTO VENDOR

1995 GMP Labeling, Inc.S197R

S511R

S195R

S197R

QUARANTINE

S188 1992 GMP Labeling

Mat:

Lot #: Amt:

By: Date:

ROLL LABELS STATUS (S series)


QUARANTINELot #: Amt:

Date: By:

S189

QUARANTINES190 1992 GMP Labeling

A MULTI-USE LABEL!Use labels Q004 through Q009 in this

space to indicate changing status such asAPPROVED or REJECTED

IN PROCESS


Mat:

Lot #: Amt:

By: Date:

S452

S201

CONDITIONALRELEASE

Mat:

Lot #: P/N:

Amt:

Date: By:

Notes:

S201 1999 GMP Labeling, Inc.

800-637-4487 Prices on page 22

S451 IN PROCESS


Mat:

Lot #:

P/N:

Amt:

By:

Date:

DESIGN-YOUR-OWN SIGNS

ACCEPTED 1048APPROVED 1045CLEANED: _____________ 2318FINISHED PRODUCT 3082FOR STERILIZATION 2092IN PROCESS 2951LOT# _________________ 3080MATERIALS ON HOLD 1061MRB HOLD 1060NON-CONFORMING MATERIAL 1059NOT FOR PRODUCTION USE 1062ON TEST 2190QC HOLD 1058QUARANTINE 2187RAW MATERIALS 3081RELEASED 1041REJECTED 1057RETAINED SAMPLES 3079STERILIZED: ___________ 2845CLEANROOM 5050GMP MANUFACTURING 5008MANUFACTURING 5010MICROBIOLOGY 5065PACKAGING 5040PACKAGING & LABELING 5042PRODUCTION 5015QUALITY ASSURANCE 5020QUALITY CONTROL 5025RECEIVING 5038RESEARCH & DEVELOPMENT 5036REWORK 5018SHIPPING 5037SHIPPING & RECEIVING 5039WAREHOUSE 5030AUTHORIZED PERSONNEL ONLY 4940CAUTION: NON STERILE 2091DO NOT ENTER 4086DO NOT OPEN 4088EYE PROTECTION REQUIRED 4092GLOVES REQUIRED 4095HAIR COVERING REQUIRED 4093KEEP DOOR CLOSED 4089LAB JACKETS REQUIRED 4096PROPER ATTIRE REQUIRED 4087GOWNING REQUIRED 4094Magnetic fasteners (2) $1.00 6020Sign holder, gold/silver $5.95 6050

Sign size Price Sign size Price

21

DESIGN-YOUR-OWN LABELS; SIGNS; SOFTWARE

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DESIGN-YOUR-OWN LABELSCat. #Size Price

RO

LLLA

BELS

2 to 8 sq. in. 19.26 51 to 60 sq. in. 49.049 to 20 sq. in. 23.36 61 to 70 sq. in. 55.20

21 to 30 sq. in. 30.55 71 to 80 sq. in. 61.3631 to 40 sq. in. 36.72 81 to 90 sq. in. 67.5341 to 50 sq. in. 42.88 91 to 100 sq. in. 74.71

STANDARD OPERATING PROCEDURESCat. #GMProcedure Price Group

ASOP495.00

DSOP295.00

ESOP345.00

Quantity Discounts: Per GMProcedure: 2-5 items 10%; 6-11 items 15%; 12-20 items 20%.Per Group: Any 2 groups 10%; any 3 groups 15%; any 4 groups 20%: all 5 groups 25%.

Prices above are for signs up to 10 x 10. For larger sizes call for a quotation.

DESIGN-YOUR-OWN LABELS PRICINGRoll: per roll of 1000 labels. Pin-feed: per pack of 1000 labels. Sheet-feed: per pack of 250 sheets. Labels per sheet: 10LP=40; 16LP=30; 17LP=18;26LP=20; 20LP, 21LP=10; 53LP=6; 51LP, 50LP=4.Options: Two ink colors, add 50%; blank labels, deduct 50%; sequential numbering,add 50%; removable adhesive, add 10%. Fluorescent pin-feed stock, add 20%.Clear label covers: to protect printing/writing on labels. Available on rolls to match alllabel sizes. To order: specify size and use price of 50% of the corresponding customlabel price. For example:unit price for 2 x 1 label is $165.74; price for clear label is$82.87. Standard volume discounts apply.

1 x 3/8 1 104.001 x 1/2 2 105.981-1/2 x 3/8 3 150.22 1-1/2 x 1/2 4 151.201-1/2 x 3/4 5 152.201-1/2 x 1 6 154.141-3/4 x 3/4 8 161.852 x 3/4 9 166.832 x 1 10 170.212 x 1-1/4 11 172.072-3/16 x 1 13 173.102-1/2 x 1 16 173.102-1/2 x1-1/2 17 177.313 x 1 18 178.133 x 1-1/2 19 181.493 x 2 20 182.064 x 2 21 186.064 x 2-1/2 22 188.603-7/8 x 3-3/8 23 190.921 Square 29 171.141-1/2 Square 27 175.482 Square 26 176.862-1/2 Square 25 178.433 Square 24 182.061/2 Circle 65 165.191 Circle 35 169.471-1/4 Circle 34 171.431-1/2 Circle 33 172.702 Circle 32 176.863 Circle 30 178.431-1/2 Oval 36 173.172 Oval 37 173.914 x 3 53 212.255 x 3 51 227.865 x 4 50 230.522 x 1 10PF 175.542-1/2 x 1 16PF 180.112-1/2 x 1-1/2 17PF 182.132 x 2 26PF 189.363 x 2 20PF 196.064 x 2 21PF 207.574 x 3 53PF 212.255 x 3 51PF 227.865 x 4 60PF 230.522 x 1 10LP 441.352-1/2 x 1 16LP 441.352-1/2 x 1-1/2 17LP 441.352 x 2 26LP 441.353 x 2 20LP 441.354 x 2 21LP 441.354 x 3 53LP 441.355 x 3 51LP 441.355 x 4 50LP 441.35

STANDARD SIGNS

Cat. #Sign

BSOP345.00

CSOP345.00

PIN

-FEE

DLA

BELS

SHEE

T-FE

EDLA

BELS

All signs 2 x 10; $20.25 each

DESIGN CONTROL QS 1002 189.00ENGINEERING CHANGE REQUEST QS 1005 189.00ENGINEERING CHANGE ORDER QS 1010 189.00DOCUMENTATION CHANGE CONTROL QS 1015 189.00MASTER & HISTORY RECORDS QS 1020 189.00FINISHED PRODUCT RELEASE QS 1025 189.00REGULATORY AGENCY INSPECTION QS 1040 189.00SELF-AUDIT QS 1045 189.00PERSONNEL TRAINING PROGRAM QS 1050 189.00MANAGEMENT RESPONSIBILITY QS 1052 189.00PURCHASING CONTROL QS 1061 189.00CALIBRATION CONTROL QS 1065 189.00LABELING CONTROL QS 1070 189.00PROCESS VALIDATION QS 1072 189.00NON-CONFORMING MATERIALS QS 1080 189.00MATERIAL REVIEW BOARD QS 1085 189.00PRODUCT DISTRIBUTION RECORDS QS 1035 189.00 MEDICAL DEVICE REPORTING QS 1100 189.00SERVICING QS 1105 189.00CORRECTIVE AND PREVENTIVE ACTION QS 1102 189.00REPORTING OF FIELD CORRECTIONS AND REMOVALS QS 1103 189.00

COMPUTER SOFTWARECat. #Item Price

Terms: Net 30 days on approved credit.

The GMP Guarantee: You can return anything, any time.No discussions, no problems. You must be happy.

GMPrint for Windows (XP, ME, 2000, 9x, 3x) P100W 98.00**GMPrint is supplied FREE with a $200 order for labels.

DISPENSERSLabel dispenser, metal 4 Holds 1 roll D045 71.60Label dispenser, metal 8 Holds 2 to 3 rolls D085 85.35Label dispenser, metal 12 Holds 3 to 5 rolls D125 101.11Label dispenser, Lucite blue/green 12 Holds 3 to 5 rolls D200B 148.51Label dispenser, Lucite red/rose 12 Holds 3 to 5 rolls D200R 148.51

S081

S089

GM

P

S08

1 Cal. Date:

By:

Next Due:ID#:

Calibration Date:

By:

Next Due:

ID#: S089

19

92 G

MP

Lab

elin

g

S185

III

IIIIIIC AL I B R A T E

S182 1995 GMP Labeling, Inc.BEFORE USING

S182

5

CALIBRATION LABELS


S202

P.M.:

By:

Next Due:

ID#: S202

20

01 G

MP

Lab

elin

g, In

c.

CALIBRATIONVOID

IF SEALIS BROKEN

S103

GM

P

S1

04CALIBRATIONVOID IF SEALIS BROKEN

S103 & S104Red ink on silverLabels are tamperevident

CALIBRATIONNOT REQUIRED


S183


By:

Date:

Prev. Run:

Lot #:

Ch. By:

CLEANEDItem:

Date:

S318R

S319

R1

992

GM

P La

belin

g

Item:

By: Date:

CLEANED

S319R

S316

R1

992

GM

P La

belin

g

Item:

By: Date:

TO BE CLEANEDS316R

CLEANS315R

S315R

DIRTYS314R

S314R

S846

R1

992

GM

P La

belin

g

Item:

By: Date:

STERILIZED

S846R


Equip:

By:

Date:

Next Due:

Notes:

FILTER CHANGEDType:

S685

VOID IF SEAL

IS BROKEN

S105tamper evident

Labels shown actual size. * Also available in smaller size: 1x0.5. R signifies removable adhesive.

800-637-4487Prices on page 22

S104

PREVENTATIVE MAINTENANCE

PM Date:By:Next Due:






Equip:


S200

S179

R1

992

GM

P La

belin

g

Item:

By: Date:

DEPYROGENATEDS179R

20

LABEL DISPENSERS800-637-4487

Versatile Lucite dispenser for roll labels Labels are fully enclosed,

keeping them safe, clean,and ready-to-use

12-inch width dispenses 3 to6 rolls, depending on label size. Easily movablelabel roll separators

Attractive, see-through Lucite in two colorsblue/green (D200B) andred/rose (D200R)

Table or wall mounting

Easy accesslabels are separatedfrom the backing as you pull

Sturdy metal dispensers

Available in three sizes: 4 (1 roll) D045 ; 8 (2 to 3 rolls) D085; 12(3 to 5 rolls) D125

Simple drop-in loading

Prices on page 21

Shop on-line for labels and other GMP Labeling products.The GMP Labeling website is a fast, easy way to view and purchase our full line of GMPcompliance related products, encompassing labels,signs, Standard Operating Procedures, and refer-ence books for FDA compliance, ISO registration,and use of the CE mark. As we add products dur-ing the year we post them to the website, so youmay learn about products not listed in this catalog.

On the website you may also view (as well as download and print) our Regulatory ComplianceNewsletters which provide articles on varioustimely aspects of regulatory compliance, written byauthors with extensive experience in their fields.

WEBSITE: www.gmplabeling.com

NEW!

C091*

FOR RESEARCHUSE ONLY GMP

C

098

C098*

C077

6

Labels above shown actual size

ROLL LABELS CAUTION (C series)

FOR EXPORTONLY

C114 1998 GMP Labeling

FOR REFERENCEUSE ONLY


Waste Series labels actual size: 2.5 x 4

W932W936

C114

C090*

STERILEC090 1992 GMP Labeling

C102*

C088*

C116

W935

* Also available in smaller size: 1x0.5.

ROLL LABELS WASTE (W series)

FREEZEUPON ARRIVAL

Example of smaller size.

C087*

REFRIGERATEUPON ARRIVAL

C087

199

2 G

MP

Labe

ling

C093*

REFRIGERATEDO NOT FREEZE GMP

C

093

C085*

EXPIRATION DATE

GM

P

C09

4

C094*

800-637-4487 Prices on page 22, 23

GM

P

C085

C095*

NOT FORHUMAN USE GMP

C

095

BIOHAZARD

C118

NEW!

19

STANDARD OPERATING PROCEDURES 800-637-4487 Prices on page 21

DESIGN CONTROL: To establish and maintain procedures to control the designs of medical devices to ensure that specifieddesign requirements are met. Cat. # QS1001.ENGINEERING CHANGE REQUEST: To provide an Engineering Change Request (ECR) system to recommend the use ofchanged materials, products, procedures, processes, methods, and the defining documentation. Cat. # QS1005.ENGINEERING CHANGE ORDER: To provide an Engineering Change Order (ECO) system to initiate and authorize the use ofnew or changed materials, products, procedures, processes, methods, and the defining documentation. Cat. # QS1010.DOCUMENTATION CHANGE CONTROL: To provide a system to initiate, review, and authorize new or revised documentation.Cat. # QS1015.MASTER AND HISTORY RECORDS: To define the organization, content and use of the Master Records (MR) and HistoryRecords (HR) employed in the production of all medical products. Cat. # QS1020.FINISHED PRODUCT RELEASE: To define the system to assure that all finished products are released for commercial distri-bution only after conformance to all applicable manufacturing, quality, and regulatory requirements. Cat. # QS1025.

Compliance Group A: DOCUMENTATION Series Catalog # ASOP

REGULATORY AGENCY INSPECTION: To describe the procedure for management of inspections by regulatory agencies having legal authority over medical products manufactured or distributed. Cat. # QS1040.SELF-AUDIT: To define a system for measuring conformance to applicable standards. Cat. # QS1045.PERSONNEL TRAINING PROGRAM: To provide a system that assures that all employees are trained to properly perform theirassigned responsibilities. Cat. # QS1050.MANAGEMENT RESPONSIBILITY: To describe the responsibility of executive management for establishing, implementing, andmaintaining quality policy and organization. Cat. # QS1052.

Compliance Group B: INSPECTION Series Catalog # BSOP

PURCHASING CONTROL: To assure that all items purchased for use in or with products comply with quality requirements. Cat. # QS1061.CALIBRATION CONTROL: To ensure that specified instruments and equipment maintain the accuracy and precisionrequired to produce safe and effective products. Cat. # QS1065.LABELING CONTROL: To describe the procedure for control and accountability of product labeling. Cat. # QS1070.PROCESS VALIDATION: To establish documented validation procedures for specified manufacturing processes and activities toensure that the output of those processes and activities consistently meets specified requirements. Cat. # QS1072.

Compliance Group C: CONTROL Series Catalog # CSOP

NON-CONFORMING MATERIALS: To describe a system for control and documentation of non-conforming or discrepantmaterials. Cat. # QS1080.MATERIAL REVIEW BOARD: To define the system for control, evaluation, disposition and documentation of non-conform-ing or discrepant materials. Cat. # QS1085.PRODUCT DISTRIBUTION RECORDS: To assure that only those medical products approved for release are distributed, andthat traceability to the end user is maintained. Cat. # QS1035.

Compliance Group D: MATERIAL Series Catalog # DSOP

MEDICAL DEVICE REPORTING: To describe the procedure for mandatory reporting of adverse events and product prob-lems to the Food and Drug Administration, using MedWatch, the FDA form 3500A. Cat. # QS1100.SERVICING: To establish and maintain a system for servicing medical devices and verifying that the devices serviced meetspecified requirements. Cat. # QS1105.CORRECTIVE AND PREVENTIVE ACTION: To describe a systematic approach to the analysis of product, process and quality data to identify existing and potential causes of nonconforming product or other quality problems, and to describe theimplementation of corrective and preventive action. Cat. # QS1102.REPORTING OF FIELD CORRECTIONS AND REMOVALS: To describe the requirements and process for reporting to theFDA field corrections and removals (field remedial actions) that are initiated to reduce a risk to health. Cat. # QS1103.

Compliance Group E: FIELD Series Catalog # ESOP

C118

200

1 G

MP

Labe

ling,

Inc.

M213R

M035

M059

M079

M069

M024M193 M023

M963R

M573R

M032

M737

M793

M792

M795

7

#:

M025

ROLL LABELS MATERIALS (M series)

Labels shown actual size. R signifies removable adhesive.

A MULTI-USE LABEL!Modify this label for differentpurposes. Most C-Series labels

will fit in this space.

800-637-4487Prices on page 23STANDARD OPERATING PROCEDURES 800-637-4487

Standard Operating ProceduresGMP Labelings GMProcedures comprise a Quality Systemcombining Procedures (SOPs), reports for evidence of GMPcompliance, and log books to track compliance histories.

Easily Customized to Your NeedsThe SOPs reflect GMP and ISO 9000 requirements, and serveas a prototype or template for you to customize to your individual situation. The SOPs are furnished in computerformat for easy adaptation using a word processor. Its simple, and youll probably save weeks of work on each SOP.

18

Date: Qty:

Released By:

Notes:

Item: Sales Order # Supplier:

P/N: Ser./Lot # Qty: Date: By:

Description:

Form #:__________

Rev.:_____________

Date:____________

THIS ITEM DOES NOT MEET ALLAPPLICABLE REQUIREMENTS

Rejected By:

Date:

Reason:

MRB Convened: Date:

THIS ITEM MEETS ALLREQUIREMENTS &

DOCUMENTATION IS COMPLETE

Released By:

Date:

Notes:

PART 2. QUALITY CONTROL RELEASE

PART 3. QUALITY ASSURANCE RELEASE

PART 1. MANUFACTURING RELEASE

PRODUCT CANNOT BE RELEASED WITHOUT THE PROPER AUTHORIZATION

1994 GMP Labeling , Inc. RF2525

Observations/Notes:

Released By: ____________________________________ Date: ______________________Print Name/Title: _______________________________________________________________



Released By:

Date:

Notes:

GMPForms

Released from QuarantineFor Quality Dept.: RELEASED PRODUCT

COMPANY Quality Record No.: ______________________________

SOP#:_______________ Rev.:____________ Date:_______________

FINISHED PRODUCTRELEASE FORM

Test/Inspect. Proc. (list): SOPs (list):

Mfg. Doc. (list): SOPs (list):

Yes______ No______

REJECTED BY: Placed in QuarantineDate: By:

Quantity:

Supplier: Production Facility:

Address: Address:

Phone#: Phone #:

Contact: Phone#: Contact: Phone#:

Item: Order # Supplier I.D.#:


Other:

Form #:__________

Rev.:_____________

Date:____________

Certification: I hereby verify that the statements herein are complete and true.X ____________________________________________________________________

Print Name: Title: Phone #: Date:

Survey SentBy:

Date:

PART 1. SUPPLIER

Materials to be Purchased: P/N / CATALOG #: Specifications, documentation:

PART 2. MATERIALS

PART 3. SUPPLIER COMPLIANCE STATEMENT

Supplier's statement of compliance to reg. standards. Include all licenses & registration #s:Applicable Regulations: (1) _________________________________________ (2) _________________________________________

PART 4. MANUFACTURING/CONTROL STATEMENT

Supplier's statement verifying conformance to appropriate manufacturing and quality practices:

1994 GMP Labeling , Inc. RF6060GMPForms

STATEMENT OF COMPANY OFFICER


SOP#:_______________ Rev.:____________ Date:_______________

SUPPLIER SURVEY REPORT

Item: Model # Calibration Date:

Inst. ID: Manufact. ID#: Prev. Maint. Date:

Location: Satisf: Unsat:

Cal. Proc. #: Maint. Proc. #: By: Date:

Calibration Label; Completed & Affixed.: Out of Calibration Label; Completed & Affixed.:

By: Date: By: Date:

Reviewed & Approved By: Notes/Comments:

Date:

Form #:__________

Rev.:_____________

Date:____________

PART 2. CALIBRATION NOTES

Notice: Any unusual operation or findings must be noted.


PART 1. PREVENTIVE MAINTENANCE OBSERVATIONS

Please use for additional notes/comments.


PREVENTIVE MAINTENANCE/CALIBRATION REPORT

Record significant data/measurements/observations:


GMPForms


SOP#:_______________ Rev.:____________ Date:_______________

Reporting Forms

Standard Ope

rating Proced

ures

Log Books

SOPs are supplied in comuter format for

easy adaptation using a word

processor.

8Labels shown actual size

COMPUTER-PRINT LABELS (PF & CP series)800-637-4487

Our CP Series of Pin-feed labelsare supplied in fan-fold sheets for printing on your dot-matrix printer. CP Series labels come with preprintedheaders but without field identifiers. Because field iden-tifiers are not preprinted, you can design your ownlabels using GMPrint software.

Label Header

4 x 2 Label

Q041CP

2 x 1 Labels

Q057CP

Prices on page 23

Q006PF2 x 1 Label

Q041PF

Q057PF2 x 2 Labels

Our PF Series of Pin-feed labelsare supplied in fan-fold sheets for printing on yourdot-matrix printer. PF Series labels come with pre-printed headers and field identifiers. With GMPrintsoftware (page 14) you choose the text, typefacestyle and size to print data in the label fields.

Label Header

FieldIdentifiers

Q045PF

Q048PF

S452PF

Q058PF

S188PF

Q006CP

Q005CP

Q004CP

S186PF

Q045CP

S452CP

Q058CP

S188CP

17

DESIGN-YOUR-OWN SIGNSPrices on page 21

How to design your own signIf we dont have a standard sign to fit your needs, its easy to design your own. Use one of the Design-Your-Own Label tear-out forms and fax it to us. If there isnt enough space on the form to write your sign, use an additional piece of paper.Follow the steps below.

STYLEDecide if your sign is to be landscape (horizontal) or portrait (vertical) style.

SIZESpecify the width and height of the sign. The maximum dimensions are 24 x 24.Maximum letter size is 2 high.

MESSAGEDecide what your sign should say, and print this clearly on the form. We will set the letter size according to the dimensions of your sign.

COLORSSelect the color of the letters and the backgroundcolor of the sign. Your choices in color combinationsare:

Letters SignWhite Black, Blue, Light Blue, Green, Red,

Orange, Gray, Brown, WalnutBlack White, Yellow, Orange, Almond,

Brushed Brass, Brushed AluminumRed White, YellowBlue White, YellowIvory OakBrown IvoryYellow Red, BlackGray Black

If youd prefer some other color combination, call us.

If youd like help designing your sign call us at 800-637-4487.

MOUNTINGEach sign is shipped with two adhesive mounting pads. You may have mounting holes in the sign, at no additional cost. Specify where the holes are to be placed top or side and how many holes you want. Other mounting options are magnetic fasteners (two per sign) and a sign holder (in gold or silver) which can be screwed ornailed to a door or wall.

QUANTITYThe last step is to tell us how many signs youwant!

Use this photo of standard GMP signs to help youchoose colors.

SIGN

EXAMPLES

800-637-4487

9COMPUTER-PRINT LABELS (LP SERIES)

Sheet-feed labels, our LP Seriesare supplied on flat 81/2 x 11 sheets for yourlaser printer. These labels come with preprintedheaders, shown on this page. Using GMPrint(page 14) you specify your format and field iden-tifiers. You may also specify the type style andsize for field identifiers and data.

With the printing quality of a laser printer,your labels look just like preprinted labels!

GMP also offers blank labels for laser printingwith nothing preprinted (no headers or fieldidentifiers), allowing you to design your ownlabels for any application (page 10), or createlabels with GMPrint (page 14).

Q005LP

Q004LP

Q006LP

S007LP

2 x 2 Labels

2 x 1 Labels

Feed preprinted or blank labels into your laser printerand imprint your headers, field identifiers and data.

S186LP2 x 4 Label

Q058LP

S050LP

Q045LP

Q041LP

S452LP

S057LP

S188LP


RETAINED SAMPLES:

3079

RAW MATERIALS

3081

16

STANDARD SIGNS Prices on page 21

Enhance compliance in all areas of your company. GMP signs are color-keyed to the GMP Labeling System.Signs are engraved and laminated for durability. Actual size 2 x 10.Signs are supplied with adhesive pads for mounting. You may order yoursigns with mounting holes (specifying placement at the top or sides).Magnetic fasteners and sign holders (in gold or silver) are also available.To design your own signs see page 17.

MRB HOLD1060

RELEASED1041

APPROVED

QUARANTINE

ON TEST

IN PROCESS

MANUFACTURING

PRODUCTION

QUALITY CONTROL

QUALITYASSURANCE

MICROBIOLOGY

WAREHOUSE

PACKAGING

CLEANROOM

REJECTED

CAUTION:NOT STERILE

NON-CONFORMINGMATERIAL

STERILIZED:

CLEANED:

1045

1057

2091

2318

2187

2845

2190

1059

2951

5010

5015

5065

5025

5030

5020

5040

5050

DO NOT ENTER

GLOVESREQUIRED

PROPER ATTIREREQUIRED

EYE PROTECTIONREQUIRED

4086

4095

4087

4092

STATUS SERIES

MATERIALS ON HOLD

AUTHORIZED PERSONNEL ONLY

RESEARCH &DEVELOPMENT50

36

1061

4096

4940

2092

DO NOT OPENFINISHED PRODUCT

PACKAGING &LABELING

LOT #

GMP MANUFACTURING

4088

3082

4093

5042

3080

5008

NOT FORPRODUCTION USE10

62

LAB JACKETSREQUIRED

FORSTERILIZATION

HAIR COVERINGREQUIRED

QC HOLD1058 SHIPPING5037

RECEIVING5038

SHIPPING &RECEIVING50

39

ACCEPTED1048

4089 KEEP DOOR CLOSED

REWORK5018

CAUTION SERIESDEPARTMENT SERIES

800-637-4487

GOWNING REQUIRED

4094

You may order signs on-line at

www.gmplabeling.com

10

DESIGN-YOUR-OWN LABELS

You design the labelwe do the restDesign your custom labels following the stepsdescribed below. If you have just a general idea of whatyou want, call us and well complete the design for you,at no charge. Then we will take care of printing yourcustom labels.

You can have your custom labels supplied on rolls or, ifyou intend to imprint the labels on your computerprinter, you can have them supplied either in sheets fora laser printer or an ink jet printer, or with pin-feedholes for a dot matrix printer.

For examples of the hundreds of different labelsdesigned by our customers, see pages 12, 13.

Design your label on one of the tear-out order forms,

STYLETake these steps to design your label


INK COLORS

STOCKRoll labels White gloss Yellowgloss Green fluorescent Red fluorescent Pink fluorescent Orange fluorescent Yellow litho Bright silver foil Bright gold foil Clear Mylar White litho Process blue litho

Your options include: 80 different label sizes and shapes 12 different stock materials for roll labels,

10 different stocks for computer-print labels 5 different ink colors 18 different typefaces, in any size sequential numbering permanent or removable adhesive

then fax the form to us and we will print your labels inthe quantity requested. This service is provided withoutadditional charges for art layout, printing set-up, plates, orink changes. Turn-around is typically two days.

SIZE

Computer-print labels, sheet-feed White litho Green fluorescent Red fluorescent Yellow fluorescent Blue pastel Gray pastel Pink pastel Yellow pastel Tan pastel Green pastel

Computer-printlabels, pin-feed White litho Green fluorescent Red fluorescent

15

CREATE-YOUR-OWN LABELS 800-637-4487Prices on page 21

Blank label stockSheet-feed Pin-feed White litho White litho Green fluorescent Green fluorescent Red fluorescent Red fluorescent Yellow fluorescent Pink fluorescent Pink fluorescent Blue pastel Gray pastel Pink pastel Yellow pastel Tan pastel Green pastel

Blank label sizesSheet-feed Pin-feed10LP 2x1 in. 10PF 2x1 in.16LP 21/2 x 1 in. 16PF 21/2 x 1 in.17LP 21/2 x 11/2 in. 17PF 21/2 x 11/2 in.26LP 2 x 2 in. 26 PF 2 x 2 in.20LP 3 x 2 in. 20 PF 3 x 2 in.21LP 4 x 2 in. 21PF 4 x 2 in.53LP 4 x 3 in. 53PF 4 x 3 in.51LP 5 x 3 in. 51PF 5 x 3 in.50LP 5 x 4 in. 50PF 5 x 4 in.

Preprinted labelsSheet-feed: select from the LP Series labelsshown on page 9.

Pin-feed: select from the CP-Series and PF-Serieslabels shown on page 8.

Sheet-feed labels are available blank (shown) orpartially preprinted.

Pin-feed (fan-folded) labels are available blank or partially preprinted (shown).

Examples of partially preprinted sheet-feed labelsimprinted using GMPrint.

Roll labels are supplied on gloss or non-gloss stock.Computer-print labels are supplied on non-gloss (litho)paper so you can print on them from your computer, orwrite on them by hand. Computer-print labels come intwo styles: sheet-feed and pin-feed.Sheet-feed labels are supplied in 81/2 x 11 sheets forprinting on a laser printer or inkjet printer. Pin-feedlabels are supplied in fan-fold sheets with tractor holesfor printing on a dot matrix printer.

Choose from the standard sizes shown below, or ask usfor a custom size.

Black Blue Red Green Brown You may have up to five colors on a label.

No. Size (in.)1 1 x 3/82 1 x 1/23 11/2 x 3/84 11/2 x 1/25 11/2 x 3/46 11/2 x 18 13/4 x 3/49 2 x 3/4

10 2 x 111 2 x 11/413 23/16 x 116 21/2 x 1

No. Size (in.)17 21/2 x 11/2 18 3 x 119 3 x 11/2 20 3 x 221 4 x 222 4 x 21/223 37/8 x 33/829 1 square27 11/2 square26 2 square25 21/2 square

No. Size (in.)24 3 square65 1/2 circle35 1 circle34 11/4 circle33 11/2 circle32 2 circle30 3 circle36 11/2 oval37 2 oval53 4 x 351 5 x 350 5 x 4

Clear cover labels to protect hand writing or imprinting are available in all sizes. Roll labels can be supplied in any square size up to 26 inches. Sheet-feed labels can be supplied in any rectangular size up to 8-1/2 by 11.

Roll Labels

No. Size (in.)10LP 2 x 116LP 21/2 x 117LP 21/2 x 11/2 26LP 2 x 220LP 3 x 221LP 4 x 253LP 4 x 351LP 5 x 350LP 5 x 4

Sheet-Feed Pin-Feed

No. Size (in.)10PF 2 x 116PF 21/2 x 117PF 21/2 x 11/2 26PF 2 x 220PF 3 x 221PF 4 x 253PF 4 x 351PF 5 x 360PF 5 x 4

Standard label sizes; custom sizes on request

Date:

Phone: (

)

Company Nam

e:

Contact Name

:

GMPLabeli

ng Or call:

800-637-4487

408-522-3200

BILL TO:

SHIP TO:

Name:

Name:

Company:

Company:

Address:

Address:

City:

State:Zip:

City:

State:Zip:

Phone: (

)

Fax: (

)

Phone: (

)

Fax: (

)

Design your o

wn roll and

computer-prin

t labels

Sketch label o

utline, actual

size. If you ne

ed

more space

use a blank s

heet of paper

.

COPY

For each sec

tion of text, in

dicate typesty

le and

size, and che

ck appropriate

box for cas

e.

Type

style

Size All u

pper

cas

e

Uppe

r & lo

wer

All l

ower

cas

e

QUANTITY:

SIZE NO.

(see table on

page 11)

INK COLOR(S)

(up to five ink c

olors)

STOCK

Roll labels

White Glos

s

Yellow Glos

s

Green Fluor

escent

Red Fluore

scent

Pink Fluore

scent

Orange Fluo

rescent

Yellow Litho

Bright Silve

r Foil

Bright Gold

Foil

Clear Mylar

White Litho

Process B

lue Litho

Computer-prin

t, Pin-feed

White Litho

Green Fluor

escent

Red Fluore

scent

Computer-prin

t, Sheet-feed

White Litho

Green Fluor

escent

Red Fluore

scent

Yellow Fluo

rescent

Blue Paste

l

Gray

Pink

Yellow Past

el

Tan

Green Paste

l

TYPESTYLE (

see samples, p

age 11)

T1 Helvetica

T2 Helvetica O

blique

T3 Helvetica B

old Condensed

T4 Helvetica B

old

T5 Helvetica B

old Oblique

T6 Palatino Bo

ld

T7 Palatino Bo

ld Italic

T8 Eras Book

T9 Eras Demi

T10 Brush Scrip

t

T11 Americana

Bold

T12 Americana

Extra Bold

T13 Times Bold

T14 Century Old

Style

T15 Avant Gard

e

T16 Eurostile B

old

T17 Futura Boo

k

T18 Trade Goth

ic Bold Cond.

TYPE SIZE

S1 ABCDE

S4 ABCDE

S2 ABCDE

S5 Largest Po

ssible

S3 ABCDE

(Any point size fro

m 6 to 72 availa

ble)

Black Blue

Red Gree

n Brown

525 West Re

mington Drive

Sunnyvale, CA

94087

Purchase Ord

er No.

Visa

MasterCard

Amex

Credit Card E

xpiration Date

:

Number

:

14

CREATE-YOUR-OWN LABELS

GMPrint the easy way to create and print labels

GMPrint is a program developed specifically forusers to design and print their own labels. We supply you with partially preprinted labels orblank labels, and you do the rest.

Design made easyGMPrint runs under Windows (XP, ME, 2000, 9x or3x) on your PC. Its easy to use simply followthe directions on the screen.

Choose your label stockBlank labels are supplied in sheet-feed or pin-feed(fan-fold) form. Specify the stock color, and choosethe label size from the table. You may also specifypermanent or removable adhesive.


GMPrint is FREE witha $200 order of labels

Create your labelDepending on whether you picked blank or partially preprinted labels, type your headers, field identifiers and data into GMPrint. Choose the placement on the label, type styles and sizes,and youre done. Just tell GMPrint how may labelsto print.

Add more to your labelGMPrint will print each label with a sequentialnumber, batch data, and date stamp.Windows is a registered trademark of Microsoft Corp.

On-screeninstructions guide you increating yourown labels.

Load blank or preprinted label stock into yourprinter and imprint with GMPrint.

11

DESIGN-YOUR-OWN LABELS 800-637-4487Prices on page 21

If youd like helpin design, just call us

at 800-637-4487!

TYPE STYLE TYPE SIZEAll samples above are shown in size S3 (14 pt)

S1 Helvetica (6 pt)

S2 Helvetica (10 pt)

S3 Helvetica (14 pt)S4 Helvetica (20 pt)S5 Largest possible

T1 HelveticaT2 Helvetica ObliqueT3 Helvetica Bold CondensedT4 Helvetica BoldT5 Helvetica Bold ObliqueT6 Palatino BoldT7 Palatino Bold ItalicT8 Eras BookT9 Eras DemiT10 Brush Script

T11 Americana BoldT12 Americana

Extra BoldT13 Times BoldT14 Century Old StyleT15 Avant GardeT16 Eurostile BoldT17 Futura BookT18 Trade Gothic Bold

Condensed You may also specify any point sizefrom 6 to 72.

1312

FRAGILEMATERIAL

NewLot

Do Not UseMV/0713

PREVENTIVE MAINTENANCEBy: Date Performed:

Date Due:

P/N

LOT #

QTYDATE

RELEASEDDate

By

APPROVED

EXAMPLES OF CUSTOMER-DESIGNED LABELS800-637-4487 800-637-4487

Date:

Phone: (

)

Company Nam

e:

Contact Name

:

GMPLabeli

ng Or call:

800-637-4487

408-522-3200

BILL TO:

SHIP TO:

Name:

Name:

Company:

Company:

Address:

Address:

City:

State:Zip:

City:

State:Zip:

Phone: (

)

Fax: (

)

Phone: (

)

Fax: (

)

Design your o

wn roll and

computer-prin

t labels

Sketch label o

utline, actual

size. If you ne

ed

more space

use a blank s

heet of paper

.

COPY

For each sec

tion of text, in

dicate typesty

le and

size, and che

ck appropriate

box for cas

e.

Type

style

Size All u

pper

cas

e

Uppe

r & lo

wer

All l

ower

cas

e

QUANTITY:

SIZE NO.

(see table on

page 11)

INK COLOR(S)

(up to five ink c

olors)

STOCK

Roll labels

White Glos

s

Yellow Glos

s

Green Fluor

escent

Red Fluore

scent

Pink Fluore

scent

Orange Fluo

rescent

Yellow Litho

Bright Silve

r Foil

Bright Gold

Foil

Clear Mylar

White Litho

Process B

lue Litho

Computer-prin

t, Pin-feed

White Litho

Green Fluor

escent

Red Fluore

scent

Computer-prin

t, Sheet-feed

White Litho

Green Fluor

escent

Red Fluore

scent

Yellow Fluo

rescent

Blue Paste

l

Gray

Pink

Yellow Past

el

Tan

Green Paste

l

TYPESTYLE (

see samples, p

age 11)

T1 Helvetica

T2 Helvetica O

blique

T3 Helvetica B

old Condensed

T4 Helvetica B

old

T5 Helvetica B

old Oblique

T6 Palatino Bo

ld

T7 Palatino Bo

ld Italic

T8 Eras Book

T9 Eras Demi

T10 Brush Scrip

t

T11 Americana

Bold

T12 Americana

Extra Bold

T13 Times Bold

T14 Century Old

Style

T15 Avant Gard

e

T16 Eurostile B

old

T17 Futura Boo

k

T18 Trade Goth

ic Bold Cond.

TYPE SIZE

S1 ABCDE

S4 ABCDE

S2 ABCDE

S5 Largest Po

ssible

S3 ABCDE

(Any point size fro

m 6 to 72 availa

ble)

Black Blue

Red Gree

n Brown

525 West Re

mington Drive

Sunnyvale, CA

94087

Purchase Ord

er No.

Visa

MasterCard

Amex

Credit Card E

xpiration Date

:

Number

:

14

CREATE-YOUR-OWN LABELS

GMPrint the easy way to create and print labels

GMPrint is a program developed specifically forusers to design and print their own labels. We supply you with partially preprinted labels orblank labels, and you do the rest.

Design made easyGMPrint runs under Windows (XP, ME, 2000, 9x or3x) on your PC. Its easy to use simply followthe directions on the screen.

Choose your label stockBlank labels are supplied in sheet-feed or pin-feed(fan-fold) form. Specify the stock color, and choosethe label size from the table. You may also specifypermanent or removable adhesive.


GMPrint is FREE witha $200 order of labels

Create your labelDepending on whether you picked blank or partially preprinted labels, type your headers, field identifiers and data into GMPrint. Choose the placement on the label, type styles and sizes,and youre done. Just tell GMPrint how may labelsto print.

Add more to your labelGMPrint will print each label with a sequentialnumber, batch data, and date stamp.Windows is a registered trademark of Microsoft Corp.

On-screeninstructions guide you increating yourown labels.

Load blank or preprinted label stock into yourprinter and imprint with GMPrint.

11

DESIGN-YOUR-OWN LABELS 800-637-4487Prices on page 21

If youd like helpin design, just call us

at 800-637-4487!

TYPE STYLE TYPE SIZEAll samples above are shown in size S3 (14 pt)

S1 Helvetica (6 pt)

S2 Helvetica (10 pt)

S3 Helvetica (14 pt)S4 Helvetica (20 pt)S5 Largest possible

T1 HelveticaT2 Helvetica ObliqueT3 Helvetica Bold CondensedT4 Helvetica BoldT5 Helvetica Bold ObliqueT6 Palatino BoldT7 Palatino Bold ItalicT8 Eras BookT9 Eras DemiT10 Brush Script

T11 Americana BoldT12 Americana

Extra BoldT13 Times BoldT14 Century Old StyleT15 Avant GardeT16 Eurostile BoldT17 Futura BookT18 Trade Gothic Bold

Condensed You may also specify any point sizefrom 6 to 72.

10

DESIGN-YOUR-OWN LABELS

You design the labelwe do the restDesign your custom labels following the stepsdescribed below. If you have just a general idea of whatyou want, call us and well complete the design for you,at no charge. Then we will take care of printing yourcustom labels.

You can have your custom labels supplied on rolls or, ifyou intend to imprint the labels on your computerprinter, you can have them supplied either in sheets fora laser printer or an ink jet printer, or with pin-feedholes for a dot matrix printer.

For examples of the hundreds of different labelsdesigned by our customers, see pages 12, 13.

Design your label on one of the tear-out order forms,

STYLETake these steps to design your label


INK COLORS

STOCKRoll labels White gloss Yellowgloss Green fluorescent Red fluorescent Pink fluorescent Orange fluorescent Yellow litho Bright silver foil Bright gold foil Clear Mylar White litho Process blue litho

Your options include: 80 different label sizes and shapes 12 different stock materials for roll labels,

10 different stocks for computer-print labels 5 different ink colors 18 different typefaces, in any size sequential numbering permanent or removable adhesive

then fax the form to us and we will print your labels inthe quantity requested. This service is provided withoutadditional charges for art layout, printing set-up, plates, orink changes. Turn-around is typically two days.

SIZE

Computer-print labels, sheet-feed White litho Green fluorescent Red fluorescent Yellow fluorescent Blue pastel Gray pastel Pink pastel Yellow pastel Tan pastel Green pastel

Computer-printlabels, pin-feed White litho Green fluorescent Red fluorescent

15

CREATE-YOUR-OWN LABELS 800-637-4487Prices on page 21

Blank label stockSheet-feed Pin-feed White litho White litho Green fluorescent Green fluorescent Red fluorescent Red fluorescent Yellow fluorescent Pink fluorescent Pink fluorescent Blue pastel Gray pastel Pink pastel Yellow pastel Tan pastel Green pastel

Blank label sizesSheet-feed Pin-feed10LP 2x1 in. 10PF 2x1 in.16LP 21/2 x 1 in. 16PF 21/2 x 1 in.17LP 21/2 x 11/2 in. 17PF 21/2 x 11/2 in.26LP 2 x 2 in. 26 PF 2 x 2 in.20LP 3 x 2 in. 20 PF 3 x 2 in.21LP 4 x 2 in. 21PF 4 x 2 in.53LP 4 x 3 in. 53PF 4 x 3 in.51LP 5 x 3 in. 51PF 5 x 3 in.50LP 5 x 4 in. 50PF 5 x 4 in.

Preprinted labelsSheet-feed: select from the LP Series labelsshown on page 9.

Pin-feed: select from the CP-Series and PF-Serieslabels shown on page 8.

Sheet-feed labels are available blank (shown) orpartially preprinted.

Pin-feed (fan-folded) labels are available blank or partially preprinted (shown).

Examples of partially preprinted sheet-feed labelsimprinted using GMPrint.

Roll labels are supplied on gloss or non-gloss stock.Computer-print labels are supplied on non-gloss (litho)paper so you can print on them from your computer, orwrite on them by hand. Computer-print labels come intwo styles: sheet-feed and pin-feed.Sheet-feed labels are supplied in 81/2 x 11 sheets forprinting on a laser printer or inkjet printer. Pin-feedlabels are supplied in fan-fold sheets with tractor holesfor printing on a dot matrix printer.

Choose from the standard sizes shown below, or ask usfor a custom size.

Black Blue Red Green Brown You may have up to five colors on a label.

No. Size (in.)1 1 x 3/82 1 x 1/23 11/2 x 3/84 11/2 x 1/25 11/2 x 3/46 11/2 x 18 13/4 x 3/49 2 x 3/4

10 2 x 111 2 x 11/413 23/16 x 116 21/2 x 1

No. Size (in.)17 21/2 x 11/2 18 3 x 119 3 x 11/2 20 3 x 221 4 x 222 4 x 21/223 37/8 x 33/829 1 square27 11/2 square26 2 square25 21/2 square

No. Size (in.)24 3 square65 1/2 circle35 1 circle34 11/4 circle33 11/2 circle32 2 circle30 2 circle36 11/2 oval37 2 oval53 4 x 351 5 x 350 5 x 4

Clear cover labels to protect hand writing or imprinting are available in all sizes. Roll labels can be supplied in any square size up to 26 inches. Sheet-feed labels can be supplied in any rectangular size up to 8-1/2 by 11.

Roll Labels

No. Size (in.)10LP 2 x 116LP 21/2 x 117LP 21/2 x 11/2 26LP 2 x 220LP 3 x 221LP 4 x 253LP 4 x 351LP 5 x 350LP 5 x 4

Sheet-Feed Pin-Feed

No. Size (in.)10PF 2 x 116PF 21/2 x 117PF 21/2 x 11/2 26PF 2 x 220PF 3 x 221PF 4 x 253PF 4 x 351PF 5 x 360PF 5 x 4

Standard label sizes; custom sizes on request

9COMPUTER-PRINT LABELS (LP SERIES)

Sheet-feed labels, our LP Seriesare supplied on flat 81/2 x 11 sheets for yourlaser printer. These labels come with preprintedheaders, shown on this page. Using GMPrint(page 14) you specify your format and field iden-tifiers. You may also specify the type style andsize for field identifiers and data.

With the printing quality of a laser printer,your labels look just like preprinted labels!

GMP also offers blank labels for laser printingwith nothing preprinted (no headers or fieldidentifiers), allowing you to design your ownlabels for any application (page 10), or createlabels with GMPrint (page 14).

Q005LP

Q004LP

Q006LP

S007LP

2 x 2 Labels

2 x 1 Labels

Feed preprinted or blank labels into your laser printerand imprint your headers, field identifiers and data.

S186LP2 x 4 Label

Q058LP

S050LP

Q045LP

Q041LP

S452LP

S057LP

S188LP


RETAINED SAMPLES:

3079

RAW MATERIALS

3081

16

STANDARD SIGNS Prices on page 21

Enhance compliance in all areas of your company. GMP signs are color-keyed to the GMP Labeling System.Signs are engraved and laminated for durability. Actual size 2 x 10.Signs are supplied with adhesive pads for mounting. You may order yoursigns with mounting holes (specifying placement at the top or sides).Magnetic fasteners and sign holders (in gold or silver) are also available.To design your own signs see page 17.

MRB HOLD1060

RELEASED1041

APPROVED

QUARANTINE

ON TEST

IN PROCESS

MANUFACTURING

PRODUCTION

QUALITY CONTROL

QUALITYASSURANCE

MICROBIOLOGY

WAREHOUSE

PACKAGING

CLEANROOM

REJECTED

CAUTION:NOT STERILE

NON-CONFORMINGMATERIAL

STERILIZED:

CLEANED:

1045

1057

2091

2318

2187

2845

2190

1059

2951

5010

5015

5065

5025

5030

5020

5040

5050

DO NOT ENTER

GLOVESREQUIRED

PROPER ATTIREREQUIRED

EYE PROTECTIONREQUIRED

4086

4095

4087

4092

STATUS SERIES

MATERIALS ON HOLD

AUTHORIZED PERSONNEL ONLY

RESEARCH &DEVELOPMENT50

36

1061

4096

4940

2092

DO NOT OPENFINISHED PRODUCT

PACKAGING &LABELING

LOT #

GMP MANUFACTURING

4088

3082

4093

5042

3080

5008

NOT FORPRODUCTION USE10

62

LAB JACKETSREQUIRED

FORSTERILIZATION

HAIR COVERINGREQUIRED

QC HOLD1058 SHIPPING5037

RECEIVING5038

SHIPPING &RECEIVING50

39

ACCEPTED1048

4089 KEEP DOOR CLOSED

REWORK5018

CAUTION SERIESDEPARTMENT SERIES

800-637-4487

GOWNING REQUIRED40

94

You may order signs on-line at

www.gmplabeling.com

8Labels shown actual size

COMPUTER-PRINT LABELS (PF & CP series)800-637-4487

Our CP Series of Pin-feed labelsare supplied in fan-fold sheets for printing on your dot-matrix printer. CP Series labels come with preprintedheaders but without field identifiers. Because field iden-tifiers are not preprinted, you can design your ownlabels using GMPrint software.

Label Header

4 x 2 Label

Q041CP

2 x 1 Labels

Q057CP

Prices on page 23

Q006PF2 x 1 Label

Q041PF

Q057PF2 x 2 Labels

Our PF Series of Pin-feed labelsare supplied in fan-fold sheets for printing on yourdot-matrix printer. PF Series labels come with pre-printed headers and field identifiers. With GMPrintsoftware (page 11) you choose the text, typefacestyle and size to print data in the label fields.

Label Header

FieldIdentifiers

Q045PF

Q048PF

S452PF

Q058PF

S188PF

Q006CP

Q005CP

Q004CP

S186PF

Q045CP

S452CP

Q058CP

S188CP

17

DESIGN-YOUR-OWN SIGNSPrices on page 21

How to design your own signIf we dont have a standard sign to fit your needs, its easy to design your own. Use one of the Design-Your-Own Label tear-out forms and fax it to us. If there isnt enough space on the form to write your sign, use an additional piece of paper.Follow the steps below.

STYLEDecide if your sign is to be landscape (horizontal) or portrait (vertical) style.

SIZESpecify the width and height of the sign. The maximum dimensions are 24 x 24.Maximum letter size is 2 high.

MESSAGEDecide what your sign should say, and print this clearly on the form. We will set the letter size according to the dimensions of your sign.

COLORSSelect the color of the letters and the backgroundcolor of the sign. Your choices in color combinationsare:

Letters SignWhite Black, Blue, Light Blue, Green, Red,

Orange, Gray, Brown, WalnutBlack White, Yellow, Orange, Almond,

Brushed Brass, Brushed AluminumRed White, YellowBlue White, YellowIvory OakBrown IvoryYellow Red, BlackGray Black

If youd prefer some other color combination, call us.

If youd like help designing your sign call us at 800-637-4487.

MOUNTINGEach sign is shipped with two adhesive mounting pads. You may have mounting holes in the sign, at no additional cost. Specify where the holes are to be placed top or side and how many holes you want. Other mounting options are magnetic fasteners (two per sign) and a sign holder (in gold or silver) which can be screwed ornailed to a door or wall.

QUANTITYThe last step is to tell us how many signs youwant!

Use this photo of standard GMP signs to help youchoose colors.

SIGN

EXAMPLES

800-637-4487

M213R

M035

M059

M079

M069

M024M193 M023

M963R

M573R

M032

M737

M793

M792

M795

7

#:

M025

ROLL LABELS MATERIALS (M series)

Labels shown actual size. R signifies removable adhesive.

A MULTI-USE LABEL!Modify this label for differentpurposes. Most C-Series labels

will fit in this space.

800-637-4487Prices on page 23STANDARD OPERATING PROCEDURES 800-637-4487

Standard Operating ProceduresGMP Labelings GMProcedures comprise a Quality Systemcombining Procedures (SOPs), reports for evidence of GMPcompliance, and log books to track compliance histories.

Easily Customized to Your NeedsThe SOPs reflect GMP and ISO 9000 requirements, and serveas a prototype or template for you to customize to your individual situation. The SOPs are furnished in computerformat for easy adaptation using a word processor. Its simple, and youll probably save weeks of work on each SOP.

18

Date: Qty:

Released By:

Notes:

Item: Sales Order # Supplier:


Description:

Form #:__________

Rev.:_____________

Date:____________

THIS ITEM DOES NOT MEET ALLAPPLICABLE REQUIREMENTS

Rejected By:

Date:

Reason:

MRB Convened: Date:



Released By:

Date:

Notes:

PART 2. QUALITY CONTROL RELEASE

PART 3. QUALITY ASSURANCE RELEASE

PART 1. MANUFACTURING RELEASE

PRODUCT CANNOT BE RELEASED WITHOUT THE PROPER AUTHORIZATION


Observations/Notes:

Released By: ____________________________________ Date: ______________________Print Name/Title: _______________________________________________________________



Released By:

Date:

Notes:

GMPForms

Released from QuarantineFor Quality Dept.: RELEASED PRODUCT


SOP#:_______________ Rev.:____________ Date:_______________

FINISHED PRODUCTRELEASE FORM

Test/Inspect. Proc. (list): SOPs (list):

Mfg. Doc. (list): SOPs (list):

Yes______ No______

REJECTED BY: Placed in QuarantineDate: By:

Quantity:

Supplier: Production Facility:

Address: Address:

Phone#: Phone #:

Contact: Phone#: Contact: Phone#:

Item: Order # Supplier I.D.#:


Other:

Form #:__________

Rev.:_____________

Date:____________

Certification: I hereby verify that the statements herein are complete and true.X ____________________________________________________________________

Print Name: Title: Phone #: Date:

Survey SentBy:

Date:

PART 1. SUPPLIER

Materials to be Purchased: P/N / CATALOG #: Specifications, documentation:

PART 2. MATERIALS

PART 3. SUPPLIER COMPLIANCE STATEMENT

Supplier's statement of compliance to reg. standards. Include all licenses & registration #s:Applicable Regulations: (1) _________________________________________ (2) _________________________________________

PART 4. MANUFACTURING/CONTROL STATEMENT

Supplier's statement verifying conformance to appropriate manufacturing and quality practices:

1994 GMP Labeling , Inc. RF6060GMPForms

STATEMENT OF COMPANY OFFICER


SOP#:_______________ Rev.:____________ Date:_______________

SUPPLIER SURVEY REPORT

Item: Model # Calibration Date:

Inst. ID: Manufact. ID#: Prev. Maint. Date:

Location: Satisf: Unsat:

Cal. Proc. #: Maint. Proc. #: By: Date:

Calibration Label; Completed & Affixed.: Out of Calibration Label; Completed & Affixed.:

By: Date: By: Date:

Reviewed & Approved By: Notes/Comments:

Date:

Form #:__________

Rev.:_____________

Date:____________

PART 2. CALIBRATION NOTES



PART 1. PREVENTIVE MAINTENANCE OBSERVATIONS

Please use for additional notes/comments.


PREVENTIVE MAINTENANCE/CALIBRATION REPORT



GMPForms


SOP#:_______________ Rev.:____________ Date:_______________

Reporting Forms

Standard Ope

rating Proced

ures

Log Books

SOPs are supplied in computer format for

easy adaptation using a word

processor.

C091*

FOR RESEARCHUSE ONLY GMP

C

098

C098*

C077

6

Labels above shown actual size

ROLL LABELS CAUTION (C series)

FOR EXPORTONLY


FOR REFERENCEUSE ONLY


Waste Series labels actual size: 2.5 x 4

W932W936

C114

C090*

STERILEC090 1992 GMP Labeling

C102*

C088*

C116

W935

* Also available in smaller size: 1x0.5.

ROLL LABELS WASTE (W series)

FREEZEUPON ARRIVAL

Example of smaller size.

C087*

REFRIGERATEUPON ARRIVAL

C087

199

2 G

MP

Labe

ling

C093*

REFRIGERATEDO NOT FREEZE GMP

C

093

C085*

EXPIRATION DATE

GM

P

C09

4

C094*

800-637-4487 Prices on page 22, 23

GM

P

C085

C095*

NOT FORHUMAN USE GMP

C

095

BIOHAZARD

C118

NEW!

19

STANDARD OPERATING PROCEDURES 800-637-4487 Prices on page 21

DESIGN CONTROL: To establish and maintain procedures to control the designs of medical devices to ensure that specifieddesign requirements are met. Cat. # QS1001.ENGINEERING CHANGE REQUEST: To provide an Engineering Change Request (ECR) system to recommend the use ofchanged materials, products, procedures, processes, methods, and the defining documentation. Cat. # QS1005.ENGINEERING CHANGE ORDER: To provide an Engineering Change Order (ECO) system to initiate and authorize the use ofnew or changed materials, products, procedures, processes, methods, and the defining documentation. Cat. # QS1010.DOCUMENTATION CHANGE CONTROL: To provide a system to initiate, review, and authorize new or revised documentation.Cat. # QS1015.MASTER AND HISTORY RECORDS: To define the organization, content and use of the Master Records (MR) and HistoryRecords (HR) employed in the production of all medical products. Cat. # QS1020.FINISHED PRODUCT RELEASE: To define the system to assure that all finished products are released for commercial distri-bution only after conformance to all applicable manufacturing, quality, and regulatory requirements. Cat. # QS1025.

Compliance Group A: DOCUMENTATION Series Catalog # ASOP

REGULATORY AGENCY INSPECTION: To describe the procedure for management of inspections by regulatory agencies having legal authority over medical products manufactured or distributed. Cat. # QS1040.SELF-AUDIT: To define a system for measuring conformance to applicable standards. Cat. # QS1045.PERSONNEL TRAINING PROGRAM: To provide a system that assures that all employees are trained to properly perform theirassigned responsibilities. Cat. # QS1050.MANAGEMENT RESPONSIBILITY: To describe the responsibility of executive management for establishing, implementing, andmaintaining quality policy and organization. Cat. # QS1052.

Compliance Group B: INSPECTION Series Catalog # BSOP

PURCHASING CONTROL: To assure that all items purchased for use in or with products comply with quality requirements. Cat. # QS1061.CALIBRATION CONTROL: To ensure that specified instruments and equipment maintain the accuracy and precisionrequired to produce safe and effective products. Cat. # QS1065.LABELING CONTROL: To describe the procedure for control and accountability of product labeling. Cat. # QS1070.PROCESS VALIDATION: To establish documented validation procedures for specified manufacturing processes and activities toensure that the output of those processes and activities consistently meets specified requirements. Cat. # QS1072.

Compliance Group C: CONTROL Series Catalog # CSOP

NON-CONFORMING MATERIALS: To describe a system for control and documentation of non-conforming or discrepantmaterials. Cat. # QS1080.MATERIAL REVIEW BOARD: To define the system for control, evaluation, disposition and documentation of non-conform-ing or discrepant materials. Cat. # QS1085.PRODUCT DISTRIBUTION RECORDS: To assure that only those medical products approved for release are distributed, andthat traceability to the end user is maintained. Cat. # QS1035.

Compliance Group D: MATERIAL Series Catalog # DSOP

MEDICAL DEVICE REPORTING: To describe the procedure for mandatory reporting of adverse events and product prob-lems to the Food and Drug Administration, using MedWatch, the FDA form 3500A. Cat. # QS1100.SERVICING: To establish and maintain a system for servicing medical devices and verifying that the devices serviced meetspecified requirements. Cat. # QS1105.CORRECTIVE AND PREVENTIVE ACTION: To describe a systematic approach to the analysis of product, process and quality data to identify existing and potential causes of nonconforming product or other quality problems, and to describe theimplementation of corrective and preventive action. Cat. # QS1102.REPORTING OF FIELD CORRECTIONS AND REMOVALS: To describe the requirements and process for reporting to theFDA field corrections and removals (field remedial actions) that are initiated to reduce a risk to health. Cat. # QS1103.

Compliance Group E: FIELD Series Catalog # ESOP

C118

200

1 G

MP

Labe

ling,

Inc.

S081

S089

GM

P

S08

1 Cal. Date:

By:

Next Due:ID#:

Calibration Date:

By:

Next Due:

ID#: S089

19

92 G

MP

Lab

elin

g

S185

III

IIIIIIC A

L I B R A T E

S182 1995 GMP Labeling, Inc.BEFORE USING

S182

5

CALIBRATION LABELS


S202

P.M.:

By:

Next Due:

ID#: S202

20

01 G

MP

Lab

elin

g, In

c.

CALIBRATIONVOID

IF SEALIS BROKEN

S103

GM

P

S1

04CALIBRATIONVOID IF SEALIS BROKEN

S103 & S104Red ink on silverLabels are tamperevident

CALIBRATIONNOT REQUIRED


S183


By:

Date:

Prev. Run:

Lot #:

Ch. By:

CLEANEDItem:

Date:

S318R

S319

R1

992

GM

P La

belin

g

Item:

By: Date:

CLEANED

S319R

S316

R1

992

GM

P La

belin

g

Item:

By: Date:

TO BE CLEANEDS316R

CLEANS315R

S315R

DIRTYS314R

S314R

S846

R1

992

GM

P La

belin

g

Item:

By: Date:

STERILIZED

S846R


Equip:

By:

Date:

Next Due:

Notes:

FILTER CHANGEDType:

S685

VOID IF SEAL

IS BROKEN

S105tamper evident

Labels shown actual size. * Also available in smaller size: 1x0.5. R signifies removable adhesive.


S104

PREVENTATIVE MAINTENANCE







Equip:


S200

S179

R1

992

GM

P La

belin

g

Item:

By: Date:

DEPYROGENATEDS179R

20

LABEL DISPENSERS800-637-4487

Versatile Lucite dispenser for roll labels Labels are fully enclosed,

keeping them safe, clean,and ready-to-use

12-inch width dispenses 3 to6 rolls, depending on label size. Easily movablelabel roll separators

Attractive, see-through Lucite in two colorsblue/green (D200B) andred/rose (D200R)

Table or wall mounting

Easy accesslabels are separatedfrom the backing as you pull

Sturdy metal dispensers

Available in three sizes: 4 (1 roll) D045 ; 8 (2 to 3 rolls) D085; 12(3 to 5 rolls) D125

Simple drop-in loading

Prices on page 21

Shop on-line for labels and other GMP Labeling products.The GMP Labeling website is a fast, easy way to view and purchase our full line of GMPcompliance related products, encompassing labels,signs, Standard Operating Procedures, and refer-ence books for FDA compliance, ISO registration,and use of the CE mark. As we add products dur-ing the year we post them to the website, so youmay learn about products not listed in this catalog.

On the website you may also view (as well as download and print) our Regulatory ComplianceNewsletters which provide articles on varioustimely aspects of regulatory compliance, written byauthors with extensive experience in their fields.

WEBSITE: www.gmplabeling.com

QUANTITY DISCOUNTSFor Design-your-own labels, standard signs,

design-your-own signs and dispensers.Qty. 2-5 = 10%; 6-11 = 15%; 12-24 = 20%; 25+ = 25%.

QUARANTINE


Mat:

Lot #:

P/N:

Amt:

Pending:

Date: By:

S187S186

S188

S190

S191

Labels shown actual size. R signifies removable adhesive. 4

RETURNTO VENDOR


S511R

S195R

S197R

QUARANTINE


Mat:

Lot #: Amt:

By: Date:



QUARANTINELot #: Amt:

Date: By:

S189

QUARANTINES190 1992 GMP Labeling

A MULTI-USE LABEL!Use labels Q004 through Q009 in this

space to indicate changing status such asAPPROVED or REJECTED

IN PROCESS


Mat:

Lot #: Amt:

By: Date:

S452

S201

CONDITIONALRELEASE

Mat:

Lot #: P/N:

Amt:

Date: By:

Notes:



S451 IN PROCESS


Mat:

Lot #:

P/N:

Amt:

By:

Date:

DESIGN-YOUR-OWN SIGNS

ACCEPTED 1048APPROVED 1045CLEANED: _____________ 2318FINISHED PRODUCT 3082FOR STERILIZATION 2092IN PROCESS 2951LOT# _________________ 3080MATERIALS ON HOLD 1061MRB HOLD 1060NON-CONFORMING MATERIAL 1059NOT FOR PRODUCTION USE 1062ON TEST 2190QC HOLD 1058QUARANTINE 2187RAW MATERIALS 3081RELEASED 1041REJECTED 1057RETAINED SAMPLES 3079STERILIZED: ___________ 2845CLEANROOM 5050GMP MANUFACTURING 5008MANUFACTURING 5010MICROBIOLOGY 5065PACKAGING 5040PACKAGING & LABELING 5042PRODUCTION 5015QUALITY ASSURANCE 5020QUALITY CONTROL 5025RECEIVING 5038RESEARCH & DEVELOPMENT 5036REWORK 5018SHIPPING 5037SHIPPING & RECEIVING 5039WAREHOUSE 5030AUTHORIZED PERSONNEL ONLY 4940CAUTION: NON STERILE 2091DO NOT ENTER 4086DO NOT OPEN 4088EYE PROTECTION REQUIRED 4092GLOVES REQUIRED 4095HAIR COVERING REQUIRED 4093KEEP DOOR CLOSED 4089LAB JACKETS REQUIRED 4096PROPER ATTIRE REQUIRED 4087GOWNING REQUIRED 4094Magnetic fasteners (2) $1.00 6020Sign holder, gold/silver $5.95 6050

Sign size Price Sign size Price

21

DESIGN-YOUR-OWN LABELS; SIGNS; SOFTWAREO

RD

ER

ING

INF

OR

MA

TIO

N 800-637-4487

DESIGN-YOUR-OWN LABELSCat. #Size Price

RO

LLLA

BELS

2 to 8 sq. in. 19.26 51 to 60 sq. in. 49.049 to 20 sq. in. 23.36 61 to 70 sq. in. 55.20

21 to 30 sq. in. 30.55 71 to 80 sq. in. 61.3631 to 40 sq. in. 36.72 81 to 90 sq. in. 67.5341 to 50 sq. in. 42.88 91 to 100 sq. in. 74.71

STANDARD OPERATING PROCEDURESCat. #GMProcedure Price Group

ASOP395.00

DSOP295.00

ESOP345.00

Quantity Discounts: Per GMProcedure: 2-5 items 10%; 6-11 items 15%; 12-20 items 20%.Per Group: Any 2 groups 10%; any 3 groups 15%; any 4 groups 20%: all 5 groups 25%.

Prices above are for signs up to 10 x 10. For larger sizes call for a quotation.

DESIGN-YOUR-OWN LABELS PRICINGRoll: per roll of 1000 labels. Pin-feed: per pack of 1000 labels. Sheet-feed: per pack of 250 sheets. Labels per sheet: 10LP=40; 16LP=30; 17LP=18;26LP=20; 20LP, 21LP=10; 53LP=6; 51LP, 50LP=4.Options: Two ink colors, add 50%; blank labels, deduct 50%; sequential numbering,add 50%; removable adhesive, add 10%. Fluorescent pin-feed stock, add 20%.Clear label covers: to protect printing/writing on labels. Available on rolls to match alllabel sizes. To order: specify size and use price of 50% of the corresponding customlabel price. For example:unit price for 2 x 1 label is $165.74; price for clear label is$82.87. Standard volume discounts apply.

1 x 3/8 1 104.001 x 1/2 2 105.981-1/2 x 3/8 3 150.22 1-1/2 x 1/2 4 151.201-1/2 x 3/4 5 152.201-1/2 x 1 6 154.141-3/4 x 3/4 8 161.852 x 3/4 9 166.832 x 1 10 170.212 x 1-1/4 11 172.072-3/16 x 1 13 173.102-1/2 x 1 16 173.102-1/2 x1-1/2 17 177.313 x 1 18 178.133 x 1-1/2 19 181.493 x 2 20 182.064 x 2 21 186.064 x 2-1/2 22 188.603-7/8 x 3-3/8 23 190.921 Square 29 171.141-1/2 Square 27 175.482 Square 26 176.862-1/2 Square 25 178.433 Square 24 182.061/2 Circle 65 165.191 Circle 35 169.471-1/4 Circle 34 171.431-1/2 Circle 33 172.702 Circle 32 176.863 Circle 30 178.431-1/2 Oval 36 173.172 Oval 37 173.914 x 3 53 212.255 x 3 51 227.865 x 4 50 230.522 x 1 10PF 175.542-1/2 x 1 16PF 180.112-1/2 x 1-1/2 17PF 182.132 x 2 26PF 189.363 x 2 20PF 196.064 x 2 21PF 207.574 x 3 53PF 212.255 x 3 51PF 227.865 x 4 60PF 230.522 x 1 10LP 441.352-1/2 x 1 16LP 441.352-1/2 x 1-1/2 17LP 441.352 x 2 26LP 441.353 x 2 20LP 441.354 x 2 21LP 441.354 x 3 53LP 441.355 x 3 51LP 441.355 x 4 50LP 441.35

STANDARD SIGNS

Cat. #Sign

BSOP345.00

CSOP345.00

PIN

-FEE

DLA

BELS

SHEE

T-FE

EDLA

BELS

All signs 2 x 10; $20.25 each

DESIGN CONTROL QS 1001 189.00ENGINEERING CHANGE REQUEST QS 1005 189.00ENGINEERING CHANGE ORDER QS 1010 189.00DOCUMENTATION CHANGE CONTROL QS 1015 189.00MASTER & HISTORY RECORDS QS 1020 189.00FINISHED PRODUCT RELEASE QS 1025 189.00REGULATORY AGENCY INSPECTION QS 1040 189.00SELF-AUDIT QS 1045 189.00PERSONNEL TRAINING PROGRAM QS 1050 189.00MANAGEMENT RESPONSIBILITY QS 1052 189.00PURCHASING CONTROL QS 1061 189.00CALIBRATION CONTROL QS 1065 189.00LABELING CONTROL QS 1070 189.00PROCESS VALIDATION QS 1072 189.00NON-CONFORMING MATERIALS QS 1080 189.00MATERIAL REVIEW BOARD QS 1085 189.00PRODUCT DISTRIBUTION RECORDS QS 1035 189.00 MEDICAL DEVICE REPORTING QS 1100 189.00SERVICING QS 1105 189.00CORRECTIVE AND PREVENTIVE ACTION QS 1102 189.00REPORTING OF FIELD CORRECTIONS AND REMOVALS QS 1103 189.00

COMPUTER SOFTWARECat. #Item Price

Terms: Net 30 days on approved credit.

The GMP Guarantee: You can return anything, any time.No discussions, no problems. You must be happy.

GMPrint for Windows (XP, ME, 2000, 9x, 3x) P100W 98.00**GMPrint is supplied FREE with a $200 order for labels.

DISPENSERSLabel dispenser, metal 4 Holds 1 roll D045 71.60Label dispenser, metal 8 Holds 2 to 3 rolls D085 85.35Label dispenser, metal 12 Holds 3 to 5 rolls D125 101.11Label dispenser, Lucite blue/green 12 Holds 3 to 5 rolls D200B 148.51Label dispenser, Lucite red/rose 12 Holds 3 to 5 rolls D200R 148.51

Q046

Q045

Q056

Q057

Q005Q004

Q060

Q041

Labels shown actual size. Actual label colors may vary slightly. Red & green labels on this page are fluorescent. 3

ROLL LABELS QUALITY CONTROL (Q series) 800-637-4487

Q006

Q016

Prices on page 22

Q062

Q048

Q008

Q009

Q058

Q007

Q012

Q064

Q065

Q065

OR

DE

RIN

G I

NF

OR

MA

TIO

N

800-

637-

4487

22

ROLL LABELS

APPROVED 2" x 1" Black/Fluor Green 1000 Q004 75.40 67.86 64.09 60.32 56.55APPROVED 2" x 3" Black/Fluor Green 500 Q045 72.90 65.61 61.97 58.32 54.68APPROVED 4" x 2.5" Black/Fluor Green 500 Q046 81.78 73.60 69.51 65.42 61.34CE 1" x 0.5" Black/Silver 1000 Q016 66.78 60.10 56.76 53.42 50.09RELEASED 2" x 1" Black/Fluor Green 1000 Q006 75.40 67.86 64.09 60.32 56.55RELEASED 2" x 3" Black/Fluor Green 500 Q041 72.90 65.61 61.97 58.32 54.68ACCEPTED 2" x 1" Black/Fluor Green 1000 Q008 75.40 67.86 64.09 60.32 56.55ACCEPTED 2" x 3" Black/Fluor Green 500 Q048 72.90 65.61 61.97 58.32 54.68REJECTED 2" x 1" Black/Fluor Red 1000 Q005 75.40 67.86 64.09 60.32 56.55REJECTED 2" x 1" Black/Yellow 1000 Q009 75.40 67.86 64.09 60.32 56.55REJECTED 4" x 2.5" Black/Fluor Red 500 Q056 81.78 73.60 69.51 65.42 61.34REJECTED 2" x 3" Black/Fluor Red 500 Q057 72.90 65.61 61.97 58.32 54.68QC HOLD 2" x 1" Black/Fluor Red 1000 Q007 75.40 67.86 64.09 60.32 56.55QC HOLD 2" x 3" Black/Fluor Red 500 Q058 72.90 65.61 61.97 58.32 54.68QC HOLD 2" x 3" Black/Yellow 500 Q060 72.90 65.61 61.97 58.32 54.68QC PASSED 1.5" Circle Black/Fluor Green 500 Q065 75.40 67.86 64.09 60.32 56.55HOLD 2" x 1" Black/Yellow 1000 Q012 75.40 67.86 64.09 60.32 56.55HOLD 2" x 3" Black/Yellow 500 Q062 72.90 65.61 61.97 58.32 54.68QUALITY CONTROL 2" x 3" Blue/White 500 Q064 72.90 65.61 61.97 58.32 54.68


STATUS: S SERIES (SEE PAGES 4-5)CALIBRATED 1" x 0.5" Black/White 1000 S081 66.78 60.10 56.76 53.42 50.09CALIBRATED 2" x 1" Black/White 1000 S089 75.40 67.86 64.09 60.32 56.55P.M. 2" x 1" Black/White 1000 S202 75.40 67.86 64.09 60.32 56.55CALIBRATION VOID IF SEAL IS BROKEN 0.5" circle Red/Silver 1000 S103 62.18 55.96 52.85 49.74 46.64CALIBRATION VOID IF SEAL IS BROKEN 1" x 0.5" Red/Silver 1000 S104 66.78 60.10 56.76 53.42 50.09VOID IF SEAL IS BROKEN 0.5" circle Red/Silver 1000 S105 62.18 55.96 52.85 49.74 46.64CALIBRATE BEFORE USE 2" x 1" Red/Yellow 1000 S182 75.40 67.86 64.09 60.32 56.55CALIBRATION NOT REQUIRED 2" x 1" Red/White 1000 S183 75.40 67.86 64.09 60.32 56.55DO NOT USE: OUT OF CALIBRATION 2" x 1" Black/Fluor Red 1000 S185 75.40 67.86 64.09 60.32 56.55QUARANTINE 4" x 2.5" Red/White 500 S186 81.78 73.60 69.51 65.42 61.34QUARANTINE 2" x 3" Red/White 500 S187 72.90 65.61 61.97 58.32 54.68QUARANTINE 2.5" x 1.5" Red/White 500 S188 65.70 59.13 55.85 52.56 49.28QUARANTINE 2" x 1" Black+Yellow/White 1000 S189 75.40 67.86 64.09 60.32 56.55QUARANTINE 2" x 1" Red/Yellow 1000 S190 75.40 67.86 64.09 60.32 56.55MRB QUARANTINE 2" x 3" Black/Fluor Red 500 S191 72.90 65.61 61.97 58.32 54.68REWORK REQUIRED 2" x 1" Red/White 1000 S195R 75.40 67.86 64.09 60.32 56.55RETURN TO VENDOR 2" x 1" Red/White 1000 S197R 75.40 67.86 64.09 60.32 56.55PREVENTATIVE MAINTENANCE 2" x 3" Green/White 500 S200 72.90 65.61 61.97 58.32 54.68CONDITIONAL RELEASE 2" x 3" Green/White 500 S201 72.90 65.61 61.97 58.32 54.68DIRTY 1.5" circle Red/White 1000 S314R 75.40 67.86 64.09 60.32 56.55CLEAN 1.5" circle Green/White 1000 S315R 75.40 67.86 64.09 60.32 56.55TO BE CLEANED 2.5" x 1.5" Red/Yellow 500 S316R 65.70 59.13 55.85 52.56 49.28CLEANED 2" x 3" Green/White 500 S318R 72.90 65.61 61.97 58.32 54.68CLEANED 2.5" x 1.5" Green/White 500 S319R 65.70 59.13 55.85 52.56 49.28IN PROCESS 2" x 3" Green/White 500 S451 72.90 65.61 61.97 58.32 54.68IN PROCESS 2.5" x 1.5" Green/White 500 S452 65.70 59.13 55.85 52.56 49.28ON TEST 1.5" x 2.5" Black/Yellow 500 S511R 65.70 59.13 55.85 52.56 49.28STERILIZED 2.5" x 1.5" Blue/White 500 S846R 65.70 59.13 55.85 52.56 49.28DEPYROGENATED 2.5" x 1.5" Red/White 500 S179R 65.70 59.13 55.85 52.56 49.28FILTER CHANGED 2" x 3" Black/White 500 S685 72.90 65.61 61.97 58.32 54.68CAUTION: C SERIES (SEE PAGE 6)NOT FOR CLINICAL USE 2" x 2" Red/White 500 C077 71.80 64.62 61.03 57.44 53.85FREEZE UPON ARRIVAL 3.5"x 1.25" Green/Yellow 1000 C085 82.04 73.84 69.73 65.63 61.53REFRIGERATE UPON ARRIVAL* 3.5" x 1.25" Green/Yellow 1000 C087 82.04 73.84 69.73 65.63 61.53CAUTION: BIOHAZARD* 2" x 0.75" Black/Fluor Red 1000 C088 73.15 65.84 62.18 58.52 54.86BIOHAZARD* 2" x 2" Black/Fluor Red 1000 C118 71.80 64.62 61.03 57.44 53.85STERILE* 2" x 1" Green/Yellow 1000 C090 75.40 67.86 64.09 60.32 56.55CAUTION: NON-STERILE* 2.5" x 1.5" Black/Fluor Red 500 C091 65.70 59.13 55.85 52.56 49.28REFRIGERATE: DO NOT FREEZE* 2" x 0.75" Green/Yellow 1000 C093 73.15 65.84 62.18 58.52 54.86EXPIRATION DATE* 2" x 0.75" Blue/Yellow 1000 C094 73.15 65.84 62.18 58.52 54.86

C SERIES continued on page 23

NEW!

LABELS 10% Disc.2-5 Items15% Disc.6-11 Items


25% Disc.25+ ItemsUNIT

NO.ROLLCOLORSIZE CAT.#


The GMP Labeling SystemFounded in 1987, GMP Labeling serves comp

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gmp_catalog_2001[1].pdf