This document outlines requirements for contract manufacturing and testing of cosmetics. It discusses the need for clear, controlled contracts between contract givers and acceptors to define their duties and avoid issues. A contract must establish terms like manufacturing and testing standards, product specifications, facilities audits, and prohibiting changes without consent. The objective is to define roles and ensure quality of outsourced production and analysis according to ASEAN GMP guidelines.

1. Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 11
GMP Workshop Kuala Lumpur 14-16 Nov 2005 1
Prepared by
Catherine Clare Rivera – Philippines
Approved by
ASEAN Cosmetic GMP Team
Endorsed by
ASEAN Cosmetic Committee
ASEAN GMP TRAINING MODULE
CONTRACT MANUFACTURING
& ANALYSIS

2. Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 11
GMP Workshop Kuala Lumpur 14-16 Nov 2005 2
CONTENT OF PRESENTATION
1. Objective
2. Scope
3. Contract Manufacturing & Analysis
4. Requirements of a Contract

3. Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 11
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 To define the requirements for contract
manufacturing and testing laboratory
 To establish the role and responsibilities
between the contract giver and acceptor
OBJECTIVES

4. Project co-financed by
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by Asean
European Committee
for Standardization
Implementing Agency
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GMP Workshop Kuala Lumpur 14-16 Nov 2005 4
This module will apply to contract
giver and contract acceptor
(cosmetic manufacturing facility
and testing/analysis laboratory).
SCOPE

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European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 11
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1. The conditions of contract manufacturing and analysis
should be clearly defined, agreed and controlled so as
to avoid misunderstanding which could result in a
product or work of unsatisfactory quality.
2. There should be a contract between the contract giver
and acceptor to clearly establish the duties and
responsibilities of each party.
3. The official contract must be binding in accordance to
the respective legislation of the ASEAN member
countries.
GENERAL DESCRIPTION

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European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 11
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REQUIREMENT OF CONTRACT (1)
1. The contract manufacturing acceptor
must comply with ASEAN GMP.
2. The contract analysis acceptor must be
duly accredited by the relevant appointed
accreditation agencies.

7. Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 11
GMP Workshop Kuala Lumpur 14-16 Nov 2005 7
REQUIREMENT OF CONTRACT (2)
3. The written contract must include the following:
a. Duly authorized representatives from the contract
acceptor and giver
b. Scope of work identified between the contract
acceptor and giver taking into consideration the
following:
 For contract manufacturing
• Formula development
• Prototype and acceptance evaluation
• Safety and efficacy tests, if any
• Packaging development
• Raw and packaging materials supply and testing, etc
 For contract analysis
• Sampling: sampling plan, quantity of sample, sampling
containers
• Test Protocol
• Test Format, etc

8. Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 11
GMP Workshop Kuala Lumpur 14-16 Nov 2005 8
3.c. List of products for contract manufacturing
3.d. finished product specifications including
directions for use
3.e. packing sizes, container specifications and
labeling requirements
3.f. shipping labels and instructions
3.g. storage condition, etc
REQUIREMENT OF CONTRACT (3)

9. Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 11
GMP Workshop Kuala Lumpur 14-16 Nov 2005 9
4. That both parties are jointly responsible for the
quality of the products or the tests subject of the
contract.
5. The contract giver shall have the right to audit
the manufacturing site and/or supervise the
process of testing the contracted products during
the period covered by the contract.
6. The contract acceptor shall not deviate or make
any changes to the formulation and/or
process/es agreed upon by the parties for the
manufacture or analysis of the product without
the prior consent of the contract giver.
REQUIREMENT OF CONTRACT (4)

10. Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 11
GMP Workshop Kuala Lumpur 14-16 Nov 2005 10
RELATED HYPERLINK DOCUMENTS
 Trainer Manual of Contract
Manufacturing & Analysis
 Sample of Contract Manufacturing
Agreement SOP

11. Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 11
GMP Workshop Kuala Lumpur 14-16 Nov 2005 11
REFERENCES
1. ASEAN Guidelines for Cosmetic GMP (2003)

12. Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 11
GMP Workshop Kuala Lumpur 14-16 Nov 2005 12