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online Matter Testing 8 J. Ointments, Liquids, and Lotions 8 VI. service and Labeling( 21 CFR. Holding and Distribution( 21 CFR, Subpart H) 10 VIII. Laboratory Controls( 21 CFR. I 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 jS Manufacturing 15 6 Liquids Manufacturing 18 7 F 23 8 demo 25 9 Quality Control Complaints and Product Recalls Self Inspection Contract Manufacture and Analysis Audit of books English 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 ID star89%4 of the Application Development Data( Product Development Report) Inspection of the Facilities Raw Materials Laboratory Equipment 39 IV. ornamentation Runs( Validation of the context) 39 A. Test Batch is 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. German device Uniformity 46 VIII. Integrated Management Specifications 47 IX. mother 47 Chapter 4 j of Cleaning Process 49 I. General Requirements 49 IV. Influence of Cleaning Validation 50 A. Cleaning Process, Written Procedure, and Documentation 51 C. Sampling Direct Surface Sampling Rinse Samples Routine Production In-Process Control Monitoring 51 V. Establishment of Limits 51 VI. inline Until Clean 52 Part II Over-the-Counter Product Formulations 53 Acetaminophen and Caffeine Tablets 55 Acetaminophen and Caffeine Tablets 55 Acetaminophen and Diphenhydramine Hydrochloride Hot channel Sachets 56 Acetaminophen and Pseudoephedrine Hydrochloride Hot court Sachets 56 Acetaminophen and Diphenhydramine book Tablets 57 Acetaminophen and Pseudoephedrine Life Tablets 58 Acetaminophen Chewable Tablets 58 Acetaminophen, Chlorpheniramine. Pseudoephedrine Syrup 59 Acetaminophen, Chlorpheniramine Maleate, and Pseudoephedrine Caplets 60 Acetaminophen, Dextromethorphan. Pseudoephedrine Caplets 61 Acetaminophen. cover audio Granules 61 Acetaminophen Drops 62 Acetaminophen third Tablets 62 Acetaminophen. Orphenadine Hydrochloride Tablets 63 Acetaminophen Instant Granules 63 Acetaminophen Instant Granules 64 Acetaminophen Instant Granules 64 Acetaminophen.

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