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ASEAN GMP TRAINING MODULE PRODUCTION. Prepared by Mr. Haryanto Susilo - Indonesia Ms. Yupa Tiengthavaj - Thailand Mr. Vo Van Duc - Vietnam Approved by GMP Cosmetic ASEAN team Endorsed by ASEAN Cosmetic Committee. CONTENT OF PRESENTATION. Introduction Objectives - PowerPoint PPT Presentation
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Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14 –
16 November 2005
1
Prepared by Mr. Haryanto Susilo - IndonesiaMs. Yupa Tiengthavaj - Thailand
Mr. Vo Van Duc - Vietnam
Approved by GMP Cosmetic ASEAN team
Endorsed byASEAN Cosmetic Committee
ASEAN GMP TRAINING MODULE
PRODUCTION
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
2
CONTENT OF PRESENTATION1. Introduction
Objectives Scope of production activity Basic description of production
activity Production mapping and flow
chart2. The Starting Materials3. Production Procedures
Dry Products Wet Products Aerosol Products Finished Products
4. Production Documents5. References
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
3
INTRODUCTION
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
4
To manufacture good & safe products and to deliver products with good efficacies
To standardize all actions related to production activities.
To ensure the consistency of product quality by using only approved starting materials
To identify production activities, enable follow up and traceability
To avoid cross-contamination and microbial contamination in production
To avoid any error in production
OBJECTIVES
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
5
Production activities consist of the following : receiving & recording of starting materials sampling of starting materials preparation of production documents, including master
formula weighing activities cleaning & sanitization of equipment preparation of bulk filling & packing activities reconciliation of production output proper recording of each activities to ensure
traceability of finished products quarantine and delivery to warehouse reprocessing, if necessary
SCOPE
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
6
PRODUCTION is defined as all activities starting from processing to packaging to obtain finished products
PROCESSING is part of production cycle starting from weighing of raw materials to obtain a bulk product
PACKAGING is p art of production cycle starting from bulk product to obtain the finished product
STARTING MATERIALS consist of raw materials and packaging materials used in the production of cosmetic products
BASIC DESCRIPTIONS
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
7
Production activities start from : preparation of raw materials weighing of raw materials mixing & bulk preparation filling and packaging
to obtain finished cosmetic products that can be released to the market.
Raw material preparation Weighing
Delivery to warehouse
Bulk storage
Filling & packing
Processing
Production operations must follow clearly defined procedures in accordance with approved specifications, with the objective of obtaining products of desired quality.
PRODUCTION MAPPING
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
8
PRODUCTION FLOWCHART
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
9
THE STARTING MATERIALS
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
10
The main objectives of a cosmetic manufacturer are:
• to produce finished products from a combination of starting materials
• to look after all the materials which will influence the quality of finished product
• compliance with GMP guidelines to avoid product being rejected or recalled from the market.
MAIN GOALS
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
11
All incoming materials should be quarantined immediately after receipt until they are released for use in production
Raw materials should be stored under appropriate condition.
Storage condition should be controlled, monitored and recorded
MATERIAL REQUIREMENTS (1)
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
12
Storage of materials should be orderly to avoid mix up and cross contamination
Ensure that there is an effective system in controlling stocks
Ensure that consumption of starting materials follows : FIFO ~ First-In-First-Out, or EEFO ~ Earliest Expiry, First Out.
MATERIAL BASIC REQUIREMENTS (2)
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
13
Personnel in charge of raw material purchase should have sufficient knowledge of the materials, products and suppliers of the materials
Raw materials should be purchased from qualified suppliers. Raw materials should have approved specification and deliveries are accompanied with a certificate of analysis.
it is suggested to purchase raw materials directly from manufacturers or appointed distributors .
MATERIAL BASIC REQUIREMENTS (3)
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
14
Starting materials should be checked and verifie d for their conformity to specifications and be trac
eable to the product.
Samples of raw materials should be physically ch ecked for conformity to specifications prior to rele
ase for use. Raw materials should be clearly labeled .
All materials received should be clean and check ed for appropriate protective packing to ensure n
o leakage, perforation or exposure to environment.
Deliveries of raw materials that do not comply wit h specification should be segregated and dispose d according to standard operating procedures
MATERIAL VERIFICATIONS
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
15
KEY CONSIDERATIONSSTARTING RAW MATERIALS
Capability and responsibility of purchasing personnel
Supplier credibility Checking of each consignment Clean and properly labeled outer
packing Any damage on the containers Different batches in one consignment Material records and proper
documentation
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
16
Primary and printed materials control Handling of printed packaging materials Storage and transport to avoid mix-up Issued and returned packaging materials from
production area Specific reference number for batch or
consignment Checking and recording of packaging
component Outdated or obsolete materials
KEY CONSIDERATIONSSTARTING PACKAGING MATERIALS
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
17
1. The packaging of cosmetic products must provide protection: against all adverse external influences that can alter
the properties of the product, e.g. moisture, light, oxygen and temperature variations;
against microbial contamination and physical damage;
against incorrect information and identification of the product.
2. The kind of packaging materials to be used must: not have any adverse effect on the product (e.g.
through chemical reactions, leaching of packaging materials or absorption);
be stable and product resistant (no change in properties, or affecting its protective function)
3. The final packaging material should be able to protect the product until its intended shelf-life.
QUALITY OF PACKAGING MATERIALS
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
18
Name of Material
Internal Code
Batch No / Receiving No.
Status
Expiry Date Retest Date
Receiving Date Signature
Quarantine / Release / Rejected / Hold ( Use Color)
LABELS OF INCOMING MATERIALS
Name of Material
Internal Code
Batch No.
Status
Expiry Date Retest Date
Date Signature
RELEASED
Name of Material
Internal Code
Batch No.
Status
Expiry Date Retest Date
Date Signature
HOLD
Name of Material
Internal Code
Batch No.
Status
Expiry Date
Date Signature
REJECTED
Name of Material
Internal Code
Batch No.
Status
Expiry Date Date Received
Date Signature
QUARANTINE
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
19
Name of Material
Internal Code
Batch No / Receiving No.
Status
Expiry Date Retest Date
Receiving Date 14- 06-2005 Signature Tia
QUARANTINE
Alcohol
AL 001
11/OF/2005
Sampled containers identificationA procedure has to be followed for sampling the material.
The containers from which samples were taken, should be identified (e.g. a label).
SAMPLING LABEL
Nina
1 of 121 of 12Sample hasbeen taken
by QC
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
20
Clearly marked Rejected materials should be clearly marked
as such.
Stored separately in off-limits area Access to the area should be controlled.
Actions: rejected materials should be returned to the
suppliers, destroyed or reprocessed; the action should be described and defined in
a procedure; the action to be taken should be approved by
authorized personnel; the action and approval must be recorded.
REJECTED MATERIALS
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
21
All waste materials should be properly handled
Should be stored properly and in a safe place
Toxic and flammable materials should be stored in a suitable designed, separated and enclosed area
Should not be allowed to accumulate
WASTE MATERIALS HANDLING
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
22
Other materials maybe present in manufacturing site:
Rodenticides, insecticides, sanitizing material used for specific purposes have toxic & hazardous properties
Avoid risk of contamination of equipment starting materials Intermediate materials bulk product
when these are used or stored on the premises
MISCELLANEOUS MATERIALS
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
23
starting materials should have been tested and passed requirements before these can be delivered to production:- tested according to approved specification
bear identification tag based on the status materials should be protected from leakage,
contamination, and delivered in good condition containers should be cleaned prior to entry in the
production area label should be placed on each weighed material quantity of weighed material is in accordance with
the requirement in the written production documents COMPANY NAME / LOGO
Raw material name/code :Supplier :Date of reception :Batch / Lot No :Quantity :Total Packing :Packing Number :
RAW MATERIAL IDENTIFICATION TAG
VERIFICATION OF MATERIAL DELIVERY
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
24
Minimum requirement is drinking-water quality based on national/country standard
Systems must be properly maintained to avoid contamination
Written/approved specifications and periodic testing are required
Monitoring record should be available
PRINCIPLE OF WATER
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
25
PRODUCTION PROCEDURES
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
26
Starting materials should be tested and approved according its specification
Production equipment should be cleaned, safe, appropriate in size, and appropriate for product type to be manufactured
Operation on different products should not be carried out simultaneously in the same room, unless there is no potential risk of mix-up and contamination
All materials should bear clear labels and batch numbers Limited access in production area, only authorized
personnel Handling of materials and products should be based on
written instruction/procedure, and where necessary, recorded
All work instructions/procedures should be written and approved
Batch manufacturing records should be well recorded by qualified and responsible personnel.
BASIC PRODUCTION PRINCIPLES
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
27
There are several guidelines that should be followed prior, during and after each production activities. These are: Area clearance or lines clearance should be done, to
avoid mix up of starting materials or finished products In-process and environmental controls should be
carried out and recorded. Indication of failure of equipment or services should be
monitored and only equipments in good condition should be available in the production area.
Cleaning procedures should be written and approved Containers should be cleaned prior to use Any deviation from requirements and expected result
should be recorded and investigated prior to start of production and prior to release of the finished product
PROCESSING GUIDANCE (1)
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
28
Any significant deviation from the expected yield should be recorded and investigated.
Checks should be carried out to ensure that pipelines and other pieces of equipment used for the transportation of products from one area to another are connected in a correct manner.
Pipes used for conveying distilled or deionized water should be sanitized according to written procedures
Measuring, weighing, recording, and control equipment should be serviced and calibrated at pre-specified intervals and records are maintained.
Repair and maintenance operations should not present any hazard to the quality of the products.
PROCESSING GUIDANCE (2)
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
29
( Company name )
QUARANTINE LABEL
Formula Number : Product Name : Manufacturing No : Batch Size : Processing Date : Transfer date & Time : Bulk transferred to : Bulk Valid until : Chemical Microbioogical Sample Finished
Product Approval Approval Micro
( ) Yes ( ) No
HOLD
BULK QUARANTINE LABEL
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
30
Both labels should be attached to the BMR
EQUIPMENT LABEL
Company Name :
EQUIPMENT :STATUS :
Checked and Verified by: Date :
Valid until :
SANITIZED
Cleaning Status of Equipment
Company Name
EQUIPMENT :STATUS :
Checked and Verified by : Date :
Valid until :
Cleaning Status of Equipment
CLEANED
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
31
Minimize risk of cross-contamination and mix-ups Different products should not be packaged in
close proximity unless there is physical segregation.
Line clearance in packaging area should be done.
Packaging line should bear the product name and batch number being produced
An appropriate procedure should be developed if labeling is delayed to avoid any mix up or mislabeling.
Verification of correct performance of printing done separately, checked and recorded.
Special care should be taken when cut labels are used and when overprinting is carried out off-line, and in manual packaging operations.
PACKAGING GUIDANCE (1)
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
32
PACKAGING GUIDANCE (2) Printed and embossed information on packaging
materials should be distinct and resistant to fading or erasing.
On-line control of the product during packaging Samples taken away from the packaging line once
opened should not be returned. Return of reworked finished products into the lot can only
be done after special inspection, investigation, approval by authorized personnel .
Any unusual discrepancy during reconciliation should be investigated before product release
Any unused batch-coded materials should be destroyed and recorded.
Excess labels and packaging materials should be returned to store; properly tagged/labeled and recorded
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
33
Weighing should be carried out : - in defined areas - using calibrated equipment.
All weighing and measurement carried out should be:
- recorded - counter checked
WEIGHING & MEASUREMENT
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
34
PREVENTION OF CONTAMINATION Prevention of contamination should be done in every
step of manufacturing processes Type of contaminant can vary, starting from dust,
gases, vapors, spray, residues from equipment, insect, microbes, or may come from operators clothing.
Area where some susceptible products are processed, such as product for babies or products applied around the eye area should be monitored periodically for its microbial content.
Cross-contamination should be avoided through proper application of preventive measures
Measures to prevent cross-contamination and their effectiveness should be checked periodically .
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
35
Done within the production area and by production people and/or Quality Control
Should be recorded and done as per approved/written SOP Sampling done to verify:
physical aspects (weight, volume, amount, etc) text on labels other performance requirements
Sampling maybe conducted based on need : during processing activity during packaging (filling & packing) activities :
random, sequential, or statistical
Samples taken away from the packaging line should not be returned if containers were opened
Record of in-process control should be part of the BMR.
IN-PROCESS CONTROL
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
36
line clearance should be done prior to processing and filling operations
prepare a clearance checklist for each operation material from previous batch should be removed from
the line filling machine should be connected to the right outlet
of the bulk storage tank number of personnel should be enough to operate the
line each personnel has clear understanding of their roles
and responsibilities in the processing or filling operation processing line should be clearly identified and labeled
with the name of the product and batch number filling lines should be physically identified with the
product name, size, batch no, and if needed the destination of products
LINE CLEARANCE
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
37
Any deviation from the procedures should be avoided as much as possible. If deviations occur, they should be approved in writing by a designated person, with the involvement of the quality control department.
Checks on yields and reconciliation of quantities should be carried out as necessary to ensure that there are no discrepancies outside acceptable limits.
These are some points to be considered in the reconciliation of the batch: quantity of starting materials, output of finished products, machine efficiency
All activities concerning reconciliation should be conducted based on written standard operating procedures.
RECONCILIATION
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
38
A product identification number/batch number should be assigned to: every finished product every bulk and semi finished product
which enables the history of the product to betraced.
A batch numbering system should be unique specific for the product non repetitive for the same product
Creation of batch number should be based on written guideline (SOP)
BATCH NUMBERING SYSTEM (1)
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
39
T he batch number should be printed on: primary packaging secondary packaging (as necessary)
A batch number may give information on : date and year of production country, manufacturer or subcontractor sequence of production
Records of batch number should be kept and maintained for every finished product until at least 1 year after the expiry date for traceability factor
BATCH NUMBERING SYSTEM (2)
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
40
Rejected product should be properly labeled and physically separated
Investigation of the root cause of rejection should be done by production and assisted by quality control
SOP in handling rejected product should be established, written and approved
If rework can be done, written procedure should be prepared by production and approved by quality control
Stability of reworked products should be verified and if necessary additional testing should be performed
HANDLING OF REJECTION OUTPUT
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
41
REPROCESSING Reprocessing is a delicate/tedious activity for a rejected
product. There should be a written policy which clearly states that
such action is allowed to be done. Reprocessing of rejected product should only be done in
exceptional cases. It should only be allowed if the quality of the product is
not negatively affected and the product quality still complies with the specifications.
It should consider additional testing of reprocessed product, e.g. stability testing of the batch.
Complete records should be maintained for reprocessed product
A reprocessed product should be given a new batch number.
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
42
DRY PRODUCTS PRODUCTION
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
43
Recommended preventive measures: use dust collector in weighing area,
mixing/blender room and in filling/packaging anti-room with air lock in between central vacuum system is recommended separate closed room apart from wet processing
area dedicated personal protective safety equipment
for operators more regular health check for operators
Problem during processing & packaging : cross contamination operators health hazard caused by powder contamination from air, equipment, facilities
DRY PRODUCT KEY ISSUES
Project co-financed by European Union Project co-
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European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
44
Handling of dry materials and products :
Weighing room for dry materials should be
separated, if necessary
For materials used in very small quantity, an
equipment with appropriate precision should be
used.
The room humidity of processing and filling activity
should be controlled, when necessary.
DRY PRODUCT HANDLING
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
45
Mixing : efficient mixing equipment should be provided dust extraction/collector unit available suitable temperature operator should be in proper uniform with glove and
mask
Bulk checking : microbial load conforms to specifications particle size and bulk density color homogeneity drop test
Filling and packing environmental control; temperature and humidity dust extraction unit operators should follow step by step procedure per
written SOP line inspection should be done per approved SOP
KEY CONSIDERATIONSLOOSE & COMPACT POWDER PRODUCTION
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European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
46
Mixing : Same as powder
Bulk checking : microbial evaluation should be done as per
specification particle size and bulk density color homogeneity bulk density
Filling and packing environmental monitoring of the filling room dust extraction/collector unit in the room Temperature and humidity control Friability, hardness and weight test
KEY CONSIDERATIONSEYE SHADOW PRODUCTION
Project co-financed by European Union Project co-
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European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
47
Mixing : the following should be
considered protect against over heating
during mixing and melting ensure the homogeneity of
color care of cross and
microbiological contamination
Bulk checking : color conformity melting point breaking point, if possible microbiological testing is
done randomly
Molding, chilling and flaming processes : Color spreading and
homogeneity Pay off (adhesiveness on
the lips) Texture performance
(shiny, smoothness, sharp, etc.)
Product weight
Prevention during flaming: avoid from the
flammable materials use finger gloves
KEY CONSIDERATIONS SEMI SOLID PRODUCT - LIPSTICK (1)
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European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
48
Melting :carefully avoid contamination during melting process.
Molding :pour hot melted lipstick gradually in the mold.
Chilling, flaming & capping: chilling and
flaming the lipstick in molds.
cleanliness and capping.
avoid contamination during process.
Sampling & testing avoid contamination
during sampling process.
check :•Visual appearance, color, odor,
•breaking point and melting point
KEY CONSIDERATIONS SEMI SOLID PRODUCT - LIPSTICK (2)
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financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
49
WET PRODUCTS PRODUCTION
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financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
50
Liquids, creams and lotions shoul d be produced in such a way as to
protect the product from microbia l and other contamination.
The use of closed systems of prod uction and transfer is recommend
ed. - Where pipe lines are used for deli
very of ingredients or bulk produc ts, care should be taken to ensure
that the systems are easy to clean.
WET PRODUCT HANDLING
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
51
Closed system closed system can be used for
production and transfer of raw and bulk materials
high maintenance & cleaning possible leakage & error of
connection can be reduced
Benefit of closed system : less manpower and faster production
leadtime avoid microbial and cross
contamination possibility of CIP cleaning safer and higher productivity
CLOSED SYSTEM PROCESS
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European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
52
Piping lines consideration : liquid raw materials & bulk transfer consider on quantity losses need intensive cleaning need additional tools : flow meters, pumps clear identification of each piping line avoid too many bending part on piping
systems avoid dead end / dead legs on piping easy handling for CIP(Cleaning in Place) verification of cleaning results & sanitization
(physical, chemical , microbiological).
PIPING LINES
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European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
53
AEROSOL PRODUCTS
PRODUCTION
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financedby Asean
European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
54
Aerosol product components :• Gas tight container (metal,
glass, plastic, tin plate or aluminum )
• Valve closure• Actuator button• Protective cups• Dip tube
AEROSOL COMPONENTS
Operation : discharge of its content by pressure of compressed gas or vapor phase generated by a propellant present in the container as a liquid.
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European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
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55
Production steps of aerosol :
filling of liquid bulk into packing,
control of bulk weight closing of packing filling of propellant control of propellant
weight final control (density,
application, etc )
Types of dispensed aerosol product Inside (content) – two or
three phases Outside ( dispensed
contents)
Product can be dispensed in various forms : Space spray – minute
particles, suspended in the air for long time.
Surface ( wet spray ) – larger particles
Surface spray as jets Foam – gas propellant
emulsified with active component of the product.
Original unchanged physical form
AEROSOL TYPE
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European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
16 November 2005
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1. Corrosion in aerosol containers: in product and /or pack damage under pressure, accelerated
2. Source of internal corrosion : change of propellant stability in product
environment attack by the product electronic interaction of dissimilar metals. water, oxygen and nature of metal in contact
with product.
3.Corrosion inhibition and prevention lacquer for internal protection anodizing
CORROSION IN AEROSOL
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Specific requirement for aerosol production area :
Separate building or location Well ventilated Explosion proof equipment & building Gas detector for flammable propellant
Propellant: Distinguishing and essential feature of an
aerosol. Liquefied gas propellant: gaseous state in
atmospheric pressure and room temperature, but liquefy on compression
Chlorofluorocarbon (freon) Hydrocarbon (propane, n-butane , iso-
butane)
AEROSOL PRODUCTION
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Filling of aerosol :a. cold filling
liquid propellant and chilled bulk closed by valve assembly
b. under cup fillingambient temperature propellant is
injected between valve and can
c. pressure fillingpropellant at room temperature is
injected under pressure through the aerosol valve itself.
AEROSOL FILLING PROCESS
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FINISHED PRODUCTS
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While awaiting approval, finished products should be placed & kept under quarantine area at the finished product warehouse.
Quarantine label indicates : Date Product name Batch No Quantity Number of pallets
FINISHED GOOD PRINCIPLES
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62
All label concerning with the status of finished products should be shown clearly
Quarantine status can be in the form of: • physical (rope, racks layers, pallet)• computer system
Rejected products : • identified and physically separated• taken out from the stock• further process (destruction, reworked,
etc)
FINISHED PRODUCT STATUS
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63
FINISHED PRODUCT STOCK CARD
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64
Sample retention program should be carried out for reference and retesting for stability evaluation and in case of
product complaint.
RETAINED SAMPLES
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PRODUCTION DOCUMENTS
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66
Production documents of each cosmetic product should consist of :
Master formula Batch manufacturing record ( BMR ) Record of Quality Control
PRODUCTION DOCUMENTS
Project co-financed by European Union Project co-
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European Committee for StandardizationImplementing Agency
Module 6GMP Workshop Kuala Lumpur 14-
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67
Master Formula is compilation of all information, related to all aspects involved in the production of a cosmetic products .
One Master Formula is applicable only for one type of product
Content of a Master Formula : Master Formula number Product name and product code/number. Issue date & name of the originator History of the Master Formula in case of revision Formula composition, both for raw & packaging material (raw
materials should be written by INCI name) List of equipment used Manufacturing procedure, including in-process control with
their limit in processing and packaging, where applicable Specification of starting materials, bulk, and finished
products Specification of intended packaging materials, and storage
condition. Components and assembly method of components in a
finished product
MASTER FORMULA
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MASTER FORMULA
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PROCESSING WORK ORDER
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PACKAGING ORDER
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PROCESSING INSTRUCTION
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DAILY PACKING REPORT
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a. Batch Manufacturing Record should be prepared for each batch of product.
b. E ach BMR should include the following : Name of product Batch formula Brief manufacturing process Batch or code number Date of the start and finish of processing and packaging Identity of individual major equipment and lines or location used Records of cleaning and sanitation of equipment used for processing
as appropriate In-process control and laboratory results, such as pH and temperatu
re test records Packaging line clearance inspection records Any sampling performed during various steps of processing Any investigation of specific failure or discrepancies Results of examinations on packed and labelled products
BATCH MANUFACTURING RECORD
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RELATED HYPERLINK DOCUMENTS
Trainer Manual of Production Reception of Starting Material Flowchart SOP Reception, Storage & Delivery of Starting M
aterials SOP Sampling of Packaging Material Weighing guidance Supplementary module “Water” SOP for Raw Material Weighing SOP Sampling of Bulk in Process
Project co-financed by European Union Project co-
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SOP Sampling for Finished Products Personal Protective Equipment Batch Processing Memo Batch Packaging Memo Master Filling Procedure SOP Handling of Product Returned SOP Finished Good Withdrawal Destructive Memo
RELATED HYPERLINK DOCUMENTS
Project co-financed by European Union Project co-
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REFERENCES
1. ASEAN Guidelines for Cosmetic GMP (2003)2. WHO, Basic principle of GMP : Materials3. WHO GMP: Main Principle for Pharmaceutical
Products4. WHO Technical Series, No 902 : Guidelines on
Packaging for Pharmaceutical products, 20025. WHO, Supplementary Training Modules on GMP:
Water for Pharmaceutical Use, part 1, 2, and 3
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