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 GMP Workshop Kuala Lumpur 14-16 Nov 2005 3  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 European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 11 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

5. 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 5 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

6. 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 6 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 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