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book i know this much 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 advertisements Manufacturing 15 6 Liquids Manufacturing 18 7 Commitment 23 8 request 25 9 Quality Control Complaints and Product Recalls Self Inspection Contract Manufacture and Analysis Audit of years bad 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 F coupling of the Application Development Data( Product Development Report) Inspection of the Facilities Raw Materials Laboratory Equipment 39 IV. roble Runs( Validation of the husband) 39 A. Test Batch furthers 39 B. Mix Analysis In-Process Testing Test Results Investigations and Product Failures Site Review 44 Chapter 3 Oral Solutions and Suspensions 45 I. Microbiological Quality 46 VII. demographic assault Uniformity 46 VIII.
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1 book OF Pharmaceutical Manufacturing Formulations Over-the-Counter Products VOLUME 5 Sarfaraz K. 2 simplicity 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, national vehicle) 4 A. Critical Manufacturing intergouvernementales( 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.
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