Guide to good manufacturing practice for …

1 pharmaceutical inspection convention . pharmaceutical inspection CO- operation scheme . PE 009-8 (Part I). 15 January 2009. Guide TO good manufacturing . practice FOR MEDICINAL PRODUCTS. PART I. PIC/S January 2009. Reproduction prohibited for commercial purposes. Reproduction for internal use is authorised, provided that the source is acknowledged. Editor: PIC/S Secretariat 14 rue du Roveray CH-1207 Geneva e-mail: web site: PE 009-8 (Part I) 15 January 2009. TABLE OF CONTENT. CHAPTER 1 - QUALITY MANAGEMENT .. 1. 1. Quality Assurance.

2 1. good manufacturing practice for Medicinal products (GMP) .. 2. Quality 3. Product Quality Review .. 4. Quality Risk Management .. 5. CHAPTER 2 - PERSONNEL .. 7. 7. 7. Key Personnel .. 7. Training .. 9. Personal Hygiene .. 9. CHAPTER 3 - PREMISES AND 11. T. 11. Premises .. 11. General .. 11. Production Area .. 11. Storage Areas .. 13. Quality Control Areas .. 13. Ancillary Areas .. 14. Equipment .. 14. CHAPTER 4 - 15. 15. 15. Documents required .. 16. Specifications .. 16. Specifications for starting and packaging materials.

3 16. Specifications for intermediate and bulk 17. Specifications for finished 17. manufacturing Formula and Processing Instructions .. 17. Packaging Instructions .. 18. Batch Processing Records .. 18. Batch Packaging Records .. 19. Procedures and records .. 20. Receipt .. 20. Sampling .. 20. Testing .. 21. Other .. 21. PE 009-8 (Part I) -i- 15 January 2009. Table of contents CHAPTER 5 - PRODUCTION .. 22. 22. 22. Prevention of cross-contamination in 23. 24. Starting 24. Processing operations - Intermediate and bulk products.

4 25. Packaging materials .. 25. Packaging operations .. 26. Finished products .. 27. Rejected, recovered and returned materials .. 28. CHAPTER 6 - QUALITY CONTROL .. 29. 29. 29. good Quality Control Laboratory 30. Documentation .. 30. Sampling .. 30. 31. On-going Stability Programme .. 32. CHAPTER 7 - CONTRACT MANUFACTURE AND 35. 35. 35. The Contract Giver .. 35. The Contract 36. The 36. CHAPTER 8 - COMPLAINTS AND PRODUCT 38. 38. Complaints .. 38. 39. CHAPTER 9 - SELF inspection .. 40. 40. PE 009-8 (Part I) - ii - 15 January 2009.

5 Chapter 1 Quality Management CHAPTER 1. QUALITY MANAGEMENT. PRINCIPLE. The holder of a manufacturing authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the company's suppliers and by the distributors.

6 To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of Quality Assurance Incorporating good manufacturing practice , and thus Quality Control and Quality Risk Management. It should be fully documented and its effectiveness monitored. All parts of the Quality Assurance systems should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities. There are additional legal responsibilities for the holder of the manufacturing authorisation and for the authorised person(s).

7 The basic concepts of Quality Assurance, good manufacturing practice , Quality Control and Quality Risk Management are inter-related. They are described here in order to emphasise their relationships and their fundamental importance to the production and control of medicinal products. QUALITY ASSURANCE. Quality Assurance is a wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use.

8 Quality Assurance therefore incorporates good manufacturing practice plus other factors outside the scope of this Guide . The system of Quality Assurance appropriate for the manufacture of medicinal products should ensure that: i. medicinal products are designed and developed in a way that takes account of the requirements of good manufacturing practice ;. ii. production and control operations are clearly specified and good manufacturing practice adopted;. iii. managerial responsibilities are clearly specified.

9 PE 009-8 (Part I) -1- 15 January 2009. Chapter 1 Quality management iv. arrangements are made for the manufacture, supply and use of the correct starting and packaging materials;. v. all necessary controls on intermediate products, and any other in- process controls and validations are carried out;. vi. the finished product is correctly processed and checked, according to the defined procedures;. vii. medicinal products are not sold or supplied before an authorised person has certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorisation and any other regulations relevant to the production, control and release of medicinal products.

10 Viii. satisfactory arrangements exist to ensure, as far as possible, that the medicinal products are stored, distributed and subsequently handled so that quality is maintained throughout their shelf life;. ix. there is a procedure for self- inspection and/or quality audit, which regularly appraises the effectiveness and applicability of the quality assurance system. good manufacturing practice FOR MEDICINAL. PRODUCTS (GMP). good manufacturing practice is that part of Quality Assurance which ensures that Medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation or product specification.