-
t. Standard Operating ProcedureMIDDLE EAST CHEMICALS
Page # lof7Document Name: Labeling of TTSPPs ProductsCopy
No:
Document # : WH-005 I Version # : 01 I Effective Date: 01 108
12013Prepared by Compliance Approval Management Approval
Replace SOPName: Mr. George Name:Dr. Soad Mahmoud Name: Dr Atef
Adib dated:Ibrahim Position: Quality Position: General - I - I
-Position: Sales Manager &Compliance Consultant Manager
(MEC)
Signature:G~orOe.. '1 Signature: 0() oJ ovJ Signature:JJtCp(J
Revised Date:- I - 1-M~hVV\.Date: 2.5 (1(2.. i)f3 Date: ~~Iq-\ ~'3
Issue date: if/:}/2()/ \+\ ~\S Issue date: zf /112d4
Record for labeling TTSPP product
1- Product:
Product Name: .
Code:
................................................................................
Pharmaceutical form: .
Strength: .
Batch/lot number: .
Manufacturing date: - - 1 - - 1- - - -
Expiry date: - - 1- -1- - - -
Manufacturerl Marketing Authorization Holder:
..........................
Quantity to be labeled:
......................................................
2- Information to be labeled:
Batch Number: .
Manufacturing Date: - - 1- - 1- - - -
Expiry Date: - - 1--I - - - -
Other Information: .
Warehouse ManagerName:Signature & Date
Responsible pharmacistName:Signature & Date
-
t. Standard Operating ProcedureMIDDLE EAST CHEMICALS
Document Name: Labeling of TTSPPs Products Page # 50f7Copy
No:
I Version # : 01 I Effective Date: 01 /08 /2013Document # :
WH-005Compliance Approval Management ApprovalPrepared by
Name: Mr. George Name:Dr. Soad Mahmoud Name: Dr Atef AdibIbrahim
Position: QualityPosition: Sales Manager &Compliance
Consultant
Signature: Geo v: te.. ~ Signature: SM..~YY\~Date: L5ft (2013
Date:.2 S-14\ ~,'
-
Standard Operating ProcedureMIDDLE EAST CHEMICALS
Document Name: Labeling of TTSPPs Products Page# 6of7Copy
No:
Document # : WH-005 I Version # : 01 I Effective Date: 01 108
12013Prepared by Compliance Approval Management Approval
Replace SOPName: Mr. George Name:Dr. Soad Mahmoud Name: Dr Atef
Adib dated:Ibrahim Position: Quality Position: General - 1- I
-Position: Sales Manager &Compliance Consultant Manager
(MEC)
Revised Date:Signature: ~~() ('%Q.4 Signature: 8\=\~~ Signature:
- I - 1-Date: 7....S/7 12 a( J Date: .2..5/=t-/~\ ~ Issue date:~~;
/?n/~
B-During Process:
Check accuracy of printed data (for each pack) Check Quality of
printing (for each pack)
Record any non- compliance .
C- After end of labeling Process
End Time: Hr Min. . .Total Time of Process: Hr Min. . .
Sub-contractor RepresentativeName:Signature & Date
Company RepresentativeName:Signature & Date
5-Reconcillation:Calculate Reconciliation & Investigate any
Loss.
Total Quantity to be labeled (A): pack
Printed Quantity (B): pack
Difference (if any): A - B = (C) ..................... Pack%
Loss =( C lA) X 100 = %
Responsible pharmacistName:Signature & Date
WH-005-FI
-
t. Standard Operating ProcedureMIDDLE EAST CHEMICALS
Page # 7of7Document Name: Labeling of TTSPPs ProductsCopy
No:
Document # : WH-005 I Version # : 01 I Effective Date: 01 /08
/2013Prepared by Compliance Approval Management Approval
Replace SOPName: Mr. George Name:Dr. Soad Mahmoud Name: Dr Atef
Adib dated:Ibrahim Position: Quality Position: General - /- /
-Position: Sales Manager &Compliance Consultant Manager
(MEC)
Signature: ~o r~ e. 4 Signature: Se~ ~ Signature: ~ ~ Revised
Date:- / - /-M~"""'"Date: ?-5/11 z-{3 Date: 25J41 ~\3 Issue date:
zr /t/lal
10. History
Effective Date Version Change Summary
t" issue01/08/2013 01
