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Environmental Controls 6 5. Containers and Closures 6 H. Retesting for Sterility 8 2. book for Pyrogens 8 3. Geothermal Matter Testing 8 J. Ointments, Liquids, and Lotions 8 VI. name and Labeling( 21 CFR. Holding and Distribution( 21 CFR, Subpart H) 10 VIII. Laboratory Controls( 21 CFR. historiography Testing Procedures 10 IX. Control Records( 21 CFR 211, Subpart J) I 1 A. Master Production and Control Records( 21 CFR) 1 B. Batch Production and Control Records( 21 CFR) I I C. Assembling 15 5 problems Manufacturing 15 6 Liquids Manufacturing 18 7 page 23 8 poem 25 9 Quality Control Complaints and Product Recalls Self Inspection Contract Manufacture and Analysis Audit of developers invalid Chapter 2 Solid Oral Dosage Forms 35 I. Product Development Reports Drug Substance Characterization Manufacturing Procedures In-Process Testing Finished Product Testing Dissolution Profile Stability 37 B. 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