CONTRACT Production AND Analysis .pptx

Contract manufacturing and analysis of pharmaceuticals

1. GOOD MANUFACTURING PRACTICES CONTRACT PRODUCTION AND ANALYSIS ANTHONY MENSAH ASARE 1

2. OUTLINE OF PRESENTATION Scenario Definitions Overview Contract Giver Contract Acceptor Contract References 2

3. SCENARIO PharmaCare Ltd., a mid-sized pharmaceutical company located in Tamale, has developed a new oral antibiotic, Ceframed-500, but lacks the necessary facilities for large-scale production and stability testing. The management is considering outsourcing the manufacturing and quality control analysis to a contract development and manufacturing organization (CDMO), Alvin Chemist in the UK. 3

4. DEFINITIONS Contract production and analysis refers to the practice where a pharmaceutical company outsources the manufacturing and quality testing to a third-party company, known as Contract Manufacturing Organization (CMO). Contract giver refers a pharmaceutical company that outsources part of its operations( such as manufacturing, packaging or quality control testing) to a third-party company. Contract acceptor refers a third-party organization that receives a contract from a contract giver to perform specific pharmaceutical activities, such as manufacturing, packaging and quality control analysis. 4

5. OVERVIEW 5

6. OVERVIEW 2 6

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9. RESPONSIBILITIES OF A CONTRACT ACCEPTOR 10

10. CONTRACT. WHAT IS ENTAILED IN IT? There must be a written contract between the contract giver and the contract acceptor which clearly establishes the responsibilities of each party, covering the outsourced activities, the products or operations to which they are related, communication processes relating to the outsourced activities and any technical arrangements made in connection with it. The contract must clearly state the way in which the authorized person, in releasing each batch of product for sale or issuing the certificate of analysis, exercises his or her full responsibility and ensures that each batch has been manufactured in and checked for, compliance with the requirements of the marketing authorization. 11

11. CONTRACT. WHAT IS ENTAILED IN IT? CONTINUED 3. Technical aspects of the contract should be drawn up by competent persons with suitable knowledge of pharmaceutical technology, analysis and GMP. All arrangements for production and analysis must be in accordance with the marketing authorization and agreed by both parties. 4. The contract should clearly describe who is responsible for contracted activities, e.g. knowledge management, technology transfer, supply chain, subcontracting, testing and releasing materials and undertaking production and QC, including in-process controls, and who has responsibility for sampling and analysis. 12

12. CONTRACT Manufacturing, analytical and distribution records, and reference samples, should be kept by, or be available to, the contract giver. Any records relevant to assessing the quality of a product in the event of complaints or a suspected defect, or to investigating in the case of a suspected falsified product or laboratory fraud, must be accessible and specified in the procedures of the contract giver. The contract should describe the handling of starting materials, intermediate, bulk and finished products, if they are rejected. It should also describe the procedure to be followed if the contract analysis shows that the tested product must be rejected. 13

13. REFERENCES Good manufacturing practices for pharmaceutical products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-seventh report. Geneva, World Health Organization, 2003 (WHO Technical Report Series, No. 908), Annex 4. Quality assurance of pharmaceuticals. WHO guidelines, related guidance and GXP training modules. Geneva, World Health Organization, 2013 (CD-ROM). 14

14. Thank you 15