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

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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


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Module 6GMP Workshop Kuala Lumpur 14-

16 November 2005

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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


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INTRODUCTION


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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


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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


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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


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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


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PRODUCTION FLOWCHART


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THE STARTING MATERIALS


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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


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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)


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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)


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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)


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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


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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


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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


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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


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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


Date Signature

RELEASED

Name of Material

Internal Code

Batch No.

Status


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


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Name of Material

Internal Code

Batch No / Receiving No.

Status


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


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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


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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


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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

MISCELLANEOUS MATERIALS


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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


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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


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PRODUCTION PROCEDURES


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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


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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)


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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)


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( 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


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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


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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.

PACKAGING GUIDANCE (1)


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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


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Weighing should be carried out : - in defined areas - using calibrated equipment.

All weighing and measurement carried out should be:

- recorded - counter checked

WEIGHING & MEASUREMENT


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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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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


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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


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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


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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)


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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)


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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


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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.


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DRY PRODUCTS PRODUCTION


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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


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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.

DRY PRODUCT HANDLING


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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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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


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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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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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WET PRODUCTS PRODUCTION


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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


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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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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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AEROSOL PRODUCTS

PRODUCTION


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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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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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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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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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FINISHED PRODUCT STOCK CARD


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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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Production documents of each cosmetic product should consist of :

Master formula Batch manufacturing record ( BMR ) Record of Quality Control

PRODUCTION DOCUMENTS


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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


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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


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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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