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Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
1Module 11Module 11
GMP Workshop Kuala Lumpur 14-16 Nov 2005GMP Workshop Kuala Lumpur 14-16 Nov 2005
Prepared byCatherine Clare Rivera – Philippines
Approved byASEAN Cosmetic GMP Team
Endorsed byASEAN Cosmetic Committee
ASEAN GMP TRAINING MODULECONTRACT MANUFACTURING
& ANALYSIS
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
2Module 11Module 11
GMP Workshop Kuala Lumpur 14-16 Nov 2005GMP Workshop Kuala Lumpur 14-16 Nov 2005
CONTENT OF PRESENTATION
1. Objective2. Scope3. Contract Manufacturing &
Analysis4. Requirements of a Contract
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
3Module 11Module 11
GMP Workshop Kuala Lumpur 14-16 Nov 2005GMP Workshop Kuala Lumpur 14-16 Nov 2005
To define the requirements for contract manufacturing and testing laboratory
To establish the role and responsibilities between the contract giver and acceptor
OBJECTIVES
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
4Module 11Module 11
GMP Workshop Kuala Lumpur 14-16 Nov 2005GMP Workshop Kuala Lumpur 14-16 Nov 2005
This module will apply to contract giver and contract acceptor (cosmetic manufacturing facility and testing/analysis laboratory).
SCOPE
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
5Module 11Module 11
GMP Workshop Kuala Lumpur 14-16 Nov 2005GMP Workshop Kuala Lumpur 14-16 Nov 2005
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
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
6Module 11Module 11
GMP Workshop Kuala Lumpur 14-16 Nov 2005GMP Workshop Kuala Lumpur 14-16 Nov 2005
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.
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
7Module 11Module 11
GMP Workshop Kuala Lumpur 14-16 Nov 2005GMP Workshop Kuala Lumpur 14-16 Nov 2005
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
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
8Module 11Module 11
GMP Workshop Kuala Lumpur 14-16 Nov 2005GMP Workshop Kuala Lumpur 14-16 Nov 2005
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 instructions3.g. storage condition, etc
REQUIREMENT OF CONTRACT (3)
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
9Module 11Module 11
GMP Workshop Kuala Lumpur 14-16 Nov 2005GMP Workshop Kuala Lumpur 14-16 Nov 2005
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)
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
10Module 11Module 11
GMP Workshop Kuala Lumpur 14-16 Nov 2005GMP Workshop Kuala Lumpur 14-16 Nov 2005
RELATED HYPERLINK DOCUMENTS
Trainer Manual of Contract Manufacturing & Analysis
Sample of Contract Manufacturing Agreement SOP
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
11Module 11Module 11
GMP Workshop Kuala Lumpur 14-16 Nov 2005GMP Workshop Kuala Lumpur 14-16 Nov 2005
REFERENCES
1. ASEAN Guidelines for Cosmetic GMP (2003)
Project co-financed by European Union Project co-
financedby Asean
European Committee for StandardizationImplementing Agency
12Module 11Module 11
GMP Workshop Kuala Lumpur 14-16 Nov 2005GMP Workshop Kuala Lumpur 14-16 Nov 2005