Project co-financed by
European Union
Project co- financed
by Asean
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
European Committee
for Standardization
Implementing Agency
Endorsed by
ASEAN Cosmetic Committee
Module 6
GMP Workshop Kuala Lumpur 14 – 16 November 2005
1
Project co-financed by
European Union
CONTENT OF PRESENTATION
Project co- financed
by Asean
1. Introduction
 Objectives
 Scope of production activity
 Basic description of production activity
 Production mapping and flow chart
2. The Starting Materials
3. Production Procedures
 Dry Products
 Wet Products
 Aerosol Products
 Finished Products
4. Production Documents
5. References
European Committee
for Standardization
Implementing Agency
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
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Project co-financed by
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Project co- financed
by Asean
INTRODUCTION
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Module 6
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Project co-financed by
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OBJECTIVES
Project co- financed
by Asean
 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
European Committee
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Implementing Agency
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
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Project co-financed by
European Union
SCOPE
Project co- financed
by Asean
Production activities consist of the following :
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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
European Committee
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Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
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Project co-financed by
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BASIC DESCRIPTIONS
Project co- financed
by Asean
 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 part 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
European Committee
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Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
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Project co-financed by
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PRODUCTION MAPPING
Raw material
preparation
Production operations must follow
clearly defined procedures in
accordance with approved
specifications, with the objective of
obtaining products of desired quality.
Project co- financed
by Asean
Weighing
Bulk storage
Processing
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.
European Committee
for Standardization
Implementing Agency
Filling & packing
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
Delivery to
warehouse
7
Project co-financed by
European Union
PRODUCTION FLOWCHART
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Project co- financed
by Asean
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Project co-financed by
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Project co- financed
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THE STARTING MATERIALS
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Project co-financed by
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Project co- financed
by Asean
MAIN GOALS
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.
European Committee
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Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
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Project co-financed by
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Project co- financed
by Asean
MATERIAL REQUIREMENTS (1)
 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
European Committee
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Project co-financed by
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Project co- financed
by Asean
MATERIAL BASIC REQUIREMENTS (2)
 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.
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Project co-financed by
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Project co- financed
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MATERIAL BASIC REQUIREMENTS (3)
 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 .
European Committee
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Module 6
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Project co-financed by
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MATERIAL VERIFICATIONS
Project co- financed
by Asean
 Starting materials should be checked and verified for
their conformity to specifications and be traceable to
the product.
 Samples of raw materials should be physically checked
for conformity to specifications prior to release for use.
Raw materials should be clearly labeled .
 All materials received should be clean and checked for
appropriate protective packing to ensure no leakage,
perforation or exposure to environment.
 Deliveries of raw materials that do not comply with
specification should be segregated and disposed
according to standard operating procedures
European Committee
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Module 6
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Project co-financed by
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KEY CONSIDERATIONS
Project co- financed
by Asean
STARTING 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
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Project co-financed by
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Project co- financed
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KEY CONSIDERATIONS
STARTING PACKAGING MATERIALS
 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
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Project co- financed
by Asean
QUALITY OF PACKAGING MATERIALS
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.
European Committee
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Project co-financed by
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LABELS OF INCOMING MATERIALS
Project co- financed
by Asean
Name of Material
Internal Code
Batch No.
Status
Name of Material
QUARANTINE
Expiry Date
Date Received
Date
Signature
Name of Material
Internal Code
Internal Code
Batch No.
Status
Batch No /
Receiving No.
Status
Quarantine / Release /
( Use Color)
Rejected / Hold
Expiry Date
Retest Date
Receiving Date
Signature
RELEASED
Expiry Date
Retest Date
Date
Signature
Name of Material
Internal Code
Batch No.
Status
REJECTED
Expiry Date
Date
Signature
Name of Material
Internal Code
Batch No.
Status
European Committee
for Standardization
Implementing Agency
HOLD
Expiry Date
Retest Date
Date
Signature
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
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Project co-financed by
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SAMPLING LABEL
Project co- financed
by Asean
 Sampled containers identification
A procedure has to be followed for sampling
the material.
The containers from which samples were
taken, should be identified (e.g. a label).
1 of 12
Sample has
been taken
by QC
Name of Material Alcohol
Internal Code
AL 001
Batch No /
Receiving No.
11/OF/2005
Status
Expiry Date
Receiving Date
European Committee
for Standardization
Implementing Agency
Nina
QUARANTINE
Retest Date
14- 06-2005 Signature
Tia
Module 6
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Project co-financed by
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REJECTED MATERIALS
Project co- financed
by Asean
 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.
European Committee
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Project co-financed by
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Project co- financed
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WASTE MATERIALS HANDLING
 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
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Project co-financed by
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MISCELLANEOUS MATERIALS
Project co- financed
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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
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Module 6
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Project co-financed by
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VERIFICATION OF MATERIAL DELIVERY
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Project co- financed
by Asean
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 IDENTIFICATION TAG
Raw material name/code
Supplier
Date of reception
Batch / Lot No
Quantity
Total Packing
Packing Number
European Committee
for Standardization
Implementing Agency
:
:
:
:
:
:
:
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
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Project co-financed by
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PRINCIPLE OF WATER
Project co- financed
by Asean
 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
European Committee
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Project co-financed by
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Project co- financed
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PRODUCTION
PROCEDURES
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Project co-financed by
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BASIC PRODUCTION PRINCIPLES
Project co- financed
by Asean
 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.
European Committee
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Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
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Project co-financed by
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PROCESSING GUIDANCE (1)
Project co- financed
by Asean
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
European Committee
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Module 6
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Project co-financed by
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PROCESSING GUIDANCE (2)
Project co- financed
by Asean
 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.
European Committee
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Project co-financed by
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BULK QUARANTINE LABEL
Project co- financed
by Asean
( Company name )
QUARANTINE LABEL
Formula Number
Product Name
Manufacturing No
Batch Size
Processing Date
Transfer date & Time
Bulk transferred to
Bulk Valid until
Chemical
Approval
:
:
:
:
:
:
:
:
Microbioogical
Approval
Sample Finished Product
Micro
(
) Yes
(
) No
HOLD
European Committee
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Project co-financed by
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Project co- financed
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EQUIPMENT LABEL
Cleaning Status of Equipment
Company Name
EQUIPMENT
STATUS
:
:
Cleaning Status of Equipment
Company Name
:
EQUIPMENT
STATUS
:
:
SANITIZED
CLEANED
Checked and Verified by
:
Valid until
:
Date
:
Checked and Verified by :
Valid until
Date
:
:
Both labels should be attached to the BMR
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Project co-financed by
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PACKAGING GUIDANCE (1)
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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.
European Committee
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Project co- financed
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Project co-financed by
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PACKAGING GUIDANCE (2)
Project co- financed
by Asean

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
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WEIGHING & MEASUREMENT
Project co- financed
by Asean
 Weighing should be carried out :
- in defined areas
- using calibrated equipment.
 All weighing and measurement carried out
should be:
- recorded
- counter checked
European Committee
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Project co-financed by
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Project co- financed
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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 .
European Committee
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Project co-financed by
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IN-PROCESS CONTROL
Project co- financed
by Asean
 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.
European Committee
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Project co-financed by
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
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
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


LINE CLEARANCE
Project co- financed
by Asean
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
European Committee
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Module 6
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RECONCILIATION
Project co- financed
by Asean
 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.
European Committee
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Project co-financed by
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Project co- financed
by Asean
BATCH NUMBERING SYSTEM (1)
 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 be
traced.
 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)
European Committee
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Project co-financed by
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Project co- financed
by Asean
BATCH NUMBERING SYSTEM (2)
 The 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
European Committee
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Module 6
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Project co-financed by
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HANDLING OF REJECTION OUTPUT
Project co- financed
by Asean
 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
European Committee
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Project co-financed by
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REPROCESSING
Project co- financed
by Asean
 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.
European Committee
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Project co-financed by
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Project co- financed
by Asean
DRY PRODUCTS
PRODUCTION
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Project co-financed by
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DRY PRODUCT KEY ISSUES
Project co- financed
by Asean
Problem during processing & packaging :
 cross contamination
 operators health hazard caused by powder
 contamination from air, equipment, facilities
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
European Committee
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Module 6
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Project co-financed by
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DRY PRODUCT HANDLING
Project co- financed
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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.
European Committee
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Project co-financed by
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KEY CONSIDERATIONS
Project co- financed
by Asean
LOOSE & COMPACT POWDER PRODUCTION
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
European Committee
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Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
45
Project co-financed by
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KEY CONSIDERATIONS
EYE SHADOW PRODUCTION
Project co- financed
by Asean
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
European Committee
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Implementing Agency
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
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Project co-financed by
European Union
KEY CONSIDERATIONS
Project co- financed
by Asean
SEMI SOLID PRODUCT - LIPSTICK (1)
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
European Committee
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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
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
47
Project co-financed by
European Union
Project co- financed
by Asean
KEY CONSIDERATIONS
SEMI SOLID PRODUCT - LIPSTICK (2)
Melting :
carefully avoid
contamination during melting
process.
Molding :
pour hot melted lipstick
gradually in the mold.
European Committee
for Standardization
Implementing Agency
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
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
48
Project co-financed by
European Union
Project co- financed
by Asean
WET
PRODUCTS
PRODUCTION
European Committee
for Standardization
Implementing Agency
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
49
Project co-financed by
European Union
WET PRODUCT HANDLING
Project co- financed
by Asean
 Liquids, creams and lotions should be
produced in such a way as to protect
the product from microbial and other
contamination.
 The use of closed systems of
production and transfer is
recommended.
 Where pipe-lines are used for delivery
of ingredients or bulk products, care
should be taken to ensure that the
systems are easy to clean.
European Committee
for Standardization
Implementing Agency
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
50
Project co-financed by
European Union
CLOSED SYSTEM PROCESS
Project co- financed
by Asean
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
European Committee
for Standardization
Implementing Agency
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
51
Project co-financed by
European Union
PIPING LINES
Project co- financed
by Asean
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).
European Committee
for Standardization
Implementing Agency
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
52
Project co-financed by
European Union
Project co- financed
by Asean
AEROSOL
PRODUCTS
PRODUCTION
European Committee
for Standardization
Implementing Agency
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
53
Project co-financed by
European Union
AEROSOL COMPONENTS
Project co- financed
by Asean
Aerosol product components :
• Gas tight container (metal, glass,
plastic, tin plate or aluminum )
• Valve closure
• Actuator button
• Protective cups
• Dip tube
Operation :
discharge of its content by
pressure of compressed gas
or vapor phase generated by a
propellant present in the
container as a liquid.
European Committee
for Standardization
Implementing Agency
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
54
Project co-financed by
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AEROSOL TYPE
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)
European Committee
for Standardization
Implementing Agency
Project co- financed
by Asean
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
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
55
Project co-financed by
European Union
CORROSION IN AEROSOL
Project co- financed
by Asean
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
European Committee
for Standardization
Implementing Agency
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
56
Project co-financed by
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AEROSOL PRODUCTION
Project co- financed
by Asean
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)
European Committee
for Standardization
Implementing Agency
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
57
Project co-financed by
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AEROSOL FILLING PROCESS
Project co- financed
by Asean
Filling of aerosol :
a. cold filling
 liquid propellant and chilled bulk closed by
valve assembly
b. under cup filling
 ambient temperature propellant is injected
between valve and can
c. pressure filling
 propellant at room temperature is injected
under pressure through the aerosol valve
itself.
European Committee
for Standardization
Implementing Agency
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
58
Project co-financed by
European Union
Project co- financed
by Asean
FINISHED PRODUCTS
European Committee
for Standardization
Implementing Agency
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
60
Project co-financed by
European Union
FINISHED GOOD PRINCIPLES
Project co- financed
by Asean
 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
European Committee
for Standardization
Implementing Agency
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
61
Project co-financed by
European Union
FINISHED PRODUCT STATUS
Project co- financed
by Asean
 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)
European Committee
for Standardization
Implementing Agency
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
62
Project co-financed by
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Project co- financed
by Asean
FINISHED
PRODUCT
STOCK
CARD
FINISHED PRODUCT STOCK CARD
COMPANY NAME :
FINISHED PRODUCT STOCK CARD
PRODUCT NAME :
Date
European Committee
for Standardization
Implementing Agency
CODE NO :
UNIT
:
IN
Report No Batch No
Qty
Date
OUT
Batch No Distributor
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
Qty
Remaining
63
Project co-financed by
European Union
RETAINED SAMPLES
Project co- financed
by Asean
Sample retention program should be carried
out for reference and retesting for stability
evaluation and in case of product complaint.
European Committee
for Standardization
Implementing Agency
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
64
Project co-financed by
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Project co- financed
by Asean
PRODUCTION
DOCUMENTS
European Committee
for Standardization
Implementing Agency
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
65
Project co-financed by
European Union
Project co- financed
by Asean
PRODUCTION DOCUMENTS
Production documents of each cosmetic
product should consist of :
 Master formula
 Batch manufacturing record ( BMR )
 Record of Quality Control
European Committee
for Standardization
Implementing Agency
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
66
Project co-financed by
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MASTER FORMULA
Project co- financed
by Asean
 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 :










European Committee
for Standardization
Implementing Agency
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
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
67
Project co-financed by
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European Committee
for Standardization
Implementing Agency
MASTER FORMULA
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
Project co- financed
by Asean
68
Project co-financed by
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PROCESSING WORK ORDER
European Committee
for Standardization
Implementing Agency
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
Project co- financed
by Asean
69
Project co-financed by
European Union
European Committee
for Standardization
Implementing Agency
PACKAGING ORDER
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
Project co- financed
by Asean
70
Project co-financed by
European Union
PROCESSING INSTRUCTION
European Committee
for Standardization
Implementing Agency
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
Project co- financed
by Asean
71
Project co-financed by
European Union
European Committee
for Standardization
Implementing Agency
DAILY PACKING REPORT
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
Project co- financed
by Asean
72
Project co-financed by
European Union
Project co- financed
by Asean
BATCH MANUFACTURING RECORD
a. Batch Manufacturing Record should be prepared for each batch of
product.
b. Each 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
temperature 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
European Committee
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Implementing Agency
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
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Project co-financed by
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Project co- financed
by Asean
RELATED HYPERLINK DOCUMENTS
 Trainer Manual of Production
 Reception of Starting Material Flowchart
 SOP Reception, Storage & Delivery of Starting Materials
 SOP Sampling of Packaging Material
 Weighing guidance
 Supplementary module “Water”
 SOP for Raw Material Weighing
 SOP Sampling of Bulk in Process
European Committee
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Implementing Agency
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
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Project co-financed by
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Project co- financed
by Asean
RELATED HYPERLINK DOCUMENTS
 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
European Committee
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Implementing Agency
Module 6
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Project co-financed by
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REFERENCES
Project co- financed
by Asean
1.
2.
3.
4.
ASEAN Guidelines for Cosmetic GMP (2003)
WHO, Basic principle of GMP : Materials
WHO GMP: Main Principle for Pharmaceutical Products
WHO Technical Series, No 902 : Guidelines on Packaging for
Pharmaceutical products, 2002
5. WHO, Supplementary Training Modules on GMP: Water for
Pharmaceutical Use, part 1, 2, and 3
European Committee
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Project co-financed by
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European Committee
for Standardization
Implementing Agency
Project co- financed
by Asean
Module 6
GMP Workshop Kuala Lumpur 14-16 November 2005
77