4.7 Recalled Products 46 48 Returned goods 46 4.9 Reagents and Culture Media aq 4.10 Waste Materials 48 441 Reference standards 48 4.12 Miscellaneous Materials 49 Documents and Formats 49 CHAPTER 5: QUALITY MANAGEMENT 5.1 t0 5.58 5.0 Introduction 5.1 Quality Assurance 5.2 Components of @.A. 5.3 Good Manufacturing Practice 5.4 Quality Control Documents and Formats CHAPTER 6: MANUFACTURING OPERATIONS AND CONTROL 6.0 Introduction 6.1 Sanitation of Manufacturing Premises 62 Mix-ups and Cross Contamination 6.3 Processing of Intermediates and Bulk products 6A Packaging Operations 65 LP.QC. 6.6 Release of Finished Product 6.7 Process Deviations 68 _Charge-in of Components 69 Time Limitations on Production 6.10 6.10 Drug product Inspection eu 6.11 Expiration Dating Catt 6.12 Calculation of Yields 6 6.13 Production Record Review 6.12 Documents and Formats 6.13 (CHAPTER 7: DOCUMENTATION AND RECORDS 7.1 to 736 7.0. Introduction a 7.1 Specifications 15 7.2 Master Produetion and Control Record 1 78 Batch Production and Control Record 79 7.4 Important SOPs and Records 7.10 7.5 Change Control Tad 7.6 Site Master File Taz Documents and Formats Ta 2 III O <