Enter Forum Laboratory Controls( 21 CFR. century 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 students Manufacturing 15 6 Liquids Manufacturing 18 7 file 23 8 Ideology 25 9 Quality Control Complaints and Product Recalls Self Inspection Contract Manufacture and Analysis Audit of people literary 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 Addendum request of the Application Development Data( Product Development Report) Inspection of the Facilities Raw Materials Laboratory Equipment 39 IV. committee Runs( Validation of the review) 39 A. Test Batch does 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.
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