Transcription of HANDBOOK OF Pharmaceutical Manufacturing …
1 HANDBOOK OFPharmaceuticalManufacturingFormulation sUncompressed Solid ProductsVOLUME 2 Sarfaraz K. NiaziCRC PRESSBoca Raton London New York Washington, of ContentsPartiRegulatory and Manufacturing Guidelines 1 Chapter 1 Global Good Manufacturing Practices Compliance 3I. Introduction 3A. General Provisions 5B.
2 Organization and Personnel 5C. Buildings and Facilities 6D. Equipment 7E. Control of Components and Drug Product Containers and Closures 8F. Production and Process Controls 9G.
3 Packaging and Labeling Controls 10H. Holding and Distribution 13I. Laboratory Controls 13J. Records and Reports 15K. Returned and Salvaged Drug Products 18 Chapter 2 Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections 21I.
4 Background 21II. Implementation 21A. Objectives 21B. Strategy 211. Biennial Inspection of Manufacturing Sites 212.
5 Inspection of Systems 223. A Scheme of Systems for the Manufacture of Drugs and Drug Products 22 III. Program Management Instructions 23A. Definitions 231. Surveillance Inspections 232.
6 Compliance Inspections 243. State of Control 244. Drug Process 245. Drug Manufacturing Inspection 24B. Inspection Planning 24C.
7 Profiles 24IV. Inspectional Observations 25A. Investigational Operations 251. General 252. Inspection Approaches 253.
8 System Inspection Coverage 264. Sampling 295. Inspection Teams 296. Reporting 29V. Analytical Observations 30A.
9 Analyzing Laboratories 30B. Analysis 30VI. Regulatory /Administrative Strategy 30 Chapter 3 Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage FormsBased on a Biopharmaceutics Classification 33I.
10 Introduction 33II. The Biopharmaceutics Classification System 33A. Solubility 33B. Permeability 34C. Dissolution 34 III.
