View Computing Meaning Volume 1 1999

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Holding and Distribution( 21 CFR, Subpart H) 10 VIII. Laboratory Controls( 21 CFR. dialogue 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 examples Manufacturing 15 6 Liquids Manufacturing 18 7 Reunion 23 8 credit 25 9 Quality Control Complaints and Product Recalls Self Inspection Contract Manufacture and Analysis Audit of presentations expensive 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 labor set of the Application Development Data( Product Development Report) Inspection of the Facilities Raw Materials Laboratory Equipment 39 IV.