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

Endorsed by
ASEAN Cosmetic Committee
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CONTENT OF PRESENTATION
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
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by Asean

INTRODUCTION

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OBJECTIVES
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

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SCOPE
by Asean

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

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BASIC DESCRIPTIONS
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
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PRODUCTION MAPPING
by Asean

Raw material
preparation Weighing

Production operations must follow

clearly defined procedures in
accordance with approved
specifications, with the objective
of obtaining products of desired Bulk storage

quality. Processing
Production activities start from :
 preparation of raw materials
 weighing of raw materials
 mixing & bulk preparation
 filling and packaging
Delivery to
Filling & packing warehouse
to obtain finished cosmetic
products that can be released to
the market.
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PRODUCTION FLOWCHART
by Asean

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THE STARTING MATERIALS

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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
European
avoid product
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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

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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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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 .

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MATERIAL VERIFICATIONS
by Asean

 Starting materials should be checked and verifie

d for their conformity to specifications and be tra
ceable to the product.
 Samples of raw materials should be physically ch
ecked for conformity to specifications prior to rel
ease for use. Raw materials should be clearly
labeled .
 All materials received should be clean and check
ed for appropriate protective packing to ensure
no leakage, perforation or exposure to
environment.
 Deliveries of raw materials that do not comply wi
th specification should be segregated and dispos
ed according toGMP
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KEY CONSIDERATIONS 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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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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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
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LABELS OF INCOMING MATERIALS

by Asean

Name of Material
Internal Code
Batch No.

Status QUARANTINE
Expiry Date Date Received
Date Signature

Name of Material Name of Material

Internal Code

Internal Code Batch No.

Status RELEASED
Batch No / Expiry Date Retest Date

Date Signature
Receiving No.
Quarantine / Release / Name of Material

Status ( Use Color)

Internal Code
Rejected / Hold Batch No.

Status REJECTED
Expiry Date Retest Date Expiry Date

Date Signature
Receiving Date Signature
Name of Material

Internal Code

Batch No.

Status HOLD
Expiry Date Retest Date
European Module 6 Date Signature
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SAMPLING LABEL
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).
Name of Material Alcohol 1 of 12
Sample has
Internal Code AL 001 been taken
by QC
Batch No /
11/OF/2005 Nina
Receiving No.
Status QUARANTINE
Expiry Date Retest Date

Receiving Date 14- 06-2005 Signature Tia

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REJECTED MATERIALS
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.
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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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MISCELLANEOUS MATERIALS
by Asean

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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VERIFICATION OF MATERIAL DELIVERY

 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
COMPANY NAME LOGO written production documents

RAW MATERIAL IDENTIFICATION TAG

Raw material name/code :

Supplier :
Date of reception :
Batch / Lot No :
Quantity :
Total Packing :
Packing Number :
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PRINCIPLE OF WATER
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

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PRODUCTION
PROCEDURES

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BASIC PRODUCTION PRINCIPLES

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
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PROCESSING GUIDANCE (1)

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
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PROCESSING GUIDANCE (2)

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.
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BULK QUARANTINE LABEL

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 Microbioogical Sample Finished
Product
Approval Approval Micro
( ) Yes
( ) No
HOLD

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EQUIPMENT LABEL
by Asean

Cleaning Status of Equipment Cleaning Status of Equipment

Company Name Company Name :

EQUIPMENT : EQUIPMENT :
STATUS : STATUS :

CLEANED SANITIZED

Checked and Verified by : Date : Checked and Verified by

: Date :

Valid until :
Valid until :

Both labels should be attached to the BMR

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PACKAGING GUIDANCE (1)

by Asean

 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
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PACKAGING GUIDANCE (2)

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

by Asean

 Weighing should be carried out :

- in defined areas
- using calibrated equipment.
 All weighing and measurement carried out sho
uld be:
- recorded
- counter checked

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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 .

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IN-PROCESS CONTROL
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.

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LINE CLEARANCE
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
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RECONCILIATION
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.
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BATCH NUMBERING SYSTEM (1)

by Asean

 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 b

e 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)
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BATCH NUMBERING SYSTEM (2)

by Asean

 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 maint
ained
 for every finished product
 until at least 1 year after the expiry date
 for traceability factor

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HANDLING OF REJECTION OUTPUT

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
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REPROCESSING
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.
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DRY
PRODUCTS
PRODUCTION

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DRY PRODUCT KEY ISSUES

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 GMP Workshop
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DRY PRODUCT HANDLING

by Asean

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
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KEY CONSIDERATIONS Project co-
financed

LOOSE & COMPACT POWDER PRODUCTION

by Asean

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
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KEY CONSIDERATIONS
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EYE SHADOW PRODUCTION

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

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KEY CONSIDERATIONS financed

by Asean

SEMI SOLID PRODUCT - LIPSTICK (1)

Mixing : Molding, chilling and
the following should be flaming processes :
considered  Color spreading and
 protect against over heating homogeneity
during mixing and melting  Pay off (adhesiveness on
 ensure the homogeneity of the lips)
color  Texture performance
 care of cross and (shiny, smoothness,
microbiological sharp, etc.)
contamination  Product weight

Bulk checking : Prevention during

 color conformity flaming:
 melting point  avoid from the
 breaking point, if possible flammable materials
 microbiological testing is  use finger gloves

done randomly
European
Committee for
Module 6
Standardization GMP Workshop Kuala Lumpur 14- 47
Implementing
Project co-financed
by European Union Project co-

KEY CONSIDERATIONS financed

by Asean

SEMI SOLID PRODUCT - LIPSTICK (2)

Melting : Chilling, flaming &
carefully avoid
capping:
 chilling and
contamination flaming the lipstick
during melting in molds.
process.  cleanliness and
capping.
 avoid
contamination
during process.

Molding : Sampling & testing

 avoid contamination
pour hot during sampling
melted lipstick process.
gradually in  check :
the mold. •Visual
appearance, color,
odor,
•breaking point
European
Committee for
Module 6 and melting point
Standardization GMP Workshop Kuala Lumpur 14- 48
Implementing
Project co-financed
by European Union Project co-
financed
by Asean

WET
PRODUCTS
PRODUCTION

European Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 49
Implementing
Project co-financed
by European Union Project co-
financed

WET PRODUCT HANDLING

by Asean

 Liquids, creams and lotions shoul

d be produced in such a way as t
o protect the product from micro
bial and other contamination.
 The use of closed systems of pro
duction and transfer is recommen
ded.
 Where pipe-lines are used for deli
very of ingredients or bulk produc
ts, care should be taken to ensur
e that the systems are easy to cle
an.
European Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 50
Implementing
Project co-financed
by European Union Project co-
financed

CLOSED SYSTEM PROCESS

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 Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 51
Implementing
Project co-financed
by European Union Project co-

PIPING LINES
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 Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 52
Implementing
Project co-financed
by European Union Project co-
financed
by Asean

AEROSOL
PRODUCTS
PRODUCTION

European Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 53
Implementing
Project co-financed
by European Union Project co-
financed

AEROSOL COMPONENTS
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
Module 6
Standardization GMP Workshop Kuala Lumpur 14- 54
Implementing
Project co-financed
by European Union Project co-

AEROSOL TYPE
financed
by Asean

Production steps of aerosol Product can be dispensed

: in various forms :
 filling of liquid bulk into  Space spray – minute
packing, particles, suspended in
 control of bulk weight
 closing of packing the air for long time.
 filling of propellant  Surface ( wet spray ) –
 control of propellant larger particles
weight  Surface spray as jets
 final control (density,  Foam – gas propellant
application, etc ) emulsified with active
component of the
Types of dispensed aerosol product.
product  Original unchanged
 Inside (content) – two or
three phases physical form
 Outside ( dispensed
contents)

European Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 55
Implementing
Project co-financed
by European Union Project co-
financed

CORROSION IN AEROSOL
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 Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 56
Implementing
Project co-financed
by European Union Project co-
financed

AEROSOL PRODUCTION
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-
European Module 6
butane)
Committee for
Standardization
Implementing
GMP Workshop Kuala Lumpur 14- 57
Project co-financed
by European Union Project co-
financed

AEROSOL FILLING PROCESS

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 Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 58
Implementing
Project co-financed
by European Union Project co-
financed
by Asean

FINISHED
PRODUCTS

European Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 60
Implementing
Project co-financed
by European Union Project co-
financed

FINISHED GOOD PRINCIPLES

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 Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 61
Implementing
Project co-financed
by European Union Project co-
financed

FINISHED PRODUCT STATUS

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 Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 62
Implementing
Project co-financed
by European Union Project co-
financed

FINISHED PRODUCT STOCK CARD

by Asean

European Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 63
Implementing
Project co-financed
by European Union Project co-
financed

RETAINED SAMPLES
by Asean

Sample retention program should be

carried out for reference and retesting
for stability evaluation and in case of
product complaint.
European Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 64
Implementing
Project co-financed
by European Union Project co-
financed
by Asean

PRODUCTION
DOCUMENTS

European Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 65
Implementing
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 Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 66
Implementing
Project co-financed
by European Union Project co-

MASTER FORMULA
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 :
 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
European
Committee for condition. Module 6
67
GMP Workshop Kuala Lumpur 14-

Standardization
Implementing Components and assembly method of components in a
Project co-financed
by European Union Project co-
financed

MASTER FORMULA
by Asean

European Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 68
Implementing
Project co-financed
by European Union Project co-
financed

PROCESSING WORK ORDER

by Asean

European Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 69
Implementing
Project co-financed
by European Union Project co-
financed

PACKAGING ORDER
by Asean

European Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 70
Implementing
Project co-financed
by European Union Project co-
financed

PROCESSING INSTRUCTION
by Asean

European Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 71
Implementing
Project co-financed
by European Union Project co-
financed

DAILY PACKING REPORT

by Asean

European Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 72
Implementing
Project co-financed
by European Union Project co-
financed

BATCH MANUFACTURING RECORD

by Asean

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 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

European Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 73
Implementing
Project co-financed
by European Union Project co-
financed

RELATED HYPERLINK DOCUMENTS

by Asean

 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
European Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 74
Implementing
Project co-financed
by European Union Project co-
financed

RELATED HYPERLINK DOCUMENTS

by Asean

 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 Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 75
Implementing
Project co-financed
by European Union Project co-
financed

REFERENCES
by Asean

1. ASEAN Guidelines for Cosmetic GMP (2003)

2. WHO, Basic principle of GMP : Materials
3. WHO GMP: Main Principle for Pharmaceutical
Products
4. 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 Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 76
Implementing
Project co-financed
by European Union Project co-
financed
by Asean

European Module 6
Committee for
Standardization GMP Workshop Kuala Lumpur 14- 77
Implementing