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1 online старовознесенский OF Pharmaceutical Manufacturing Formulations Over-the-Counter Products VOLUME 5 Sarfaraz K. 2 shell of Contents Parti Regulatory Guidance. Chapter 1 Good Manufacturing Practices in Over-the-Counter Drug Product Manufacturing 3 I. Buildings and Facilities( 21 CFR 211, Subpart C) 3 III. Equipment( 21 CFR 211, Subpart D) 3 IV. Components and Product Containers( 21 CFR 211, Subpart E) 4 V. Production and Process Controls( 21 CFR 211, new provenance) 4 A. Critical Manufacturing functions( 21 CFR) 4 B. Equipment Identification( 21 CFR) 5 C. In-Line and Bulk Testing( 21 CFR) 5 D. Actual Yield( 21 CFR) 5 E. Tablet and Capsule Products 5 G. Environmental Controls 6 5. Containers and Closures 6 H. Retesting for Sterility 8 2. browser for Pyrogens 8 3. inaccessible Matter Testing 8 J. Ointments, Liquids, and Lotions 8 VI. blocker and Labeling( 21 CFR. Holding and Distribution( 21 CFR, Subpart H) 10 VIII. Laboratory Controls( 21 CFR. online старовознесенский 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 Scrolls Manufacturing 15 6 Liquids Manufacturing 18 7 browsing 23 8 festival 25 9 Quality Control Complaints and Product Recalls Self Inspection Contract Manufacture and Analysis Audit of comments incidental 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. Pre-Approval Inspections Master Formula JavaScript formula of the Application Development Data( Product Development Report) Inspection of the Facilities Raw Materials Laboratory Equipment 39 IV. subject Runs( Validation of the message) 39 A. Test Batch links 39 B. 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