Good Manufacturing Practices for Pharmaceuticals : A Plan for Total Quality Control Book

	Preface to the Fourth Edition
	Introduction to the Fourth Edition
1	Status and Applicability of U.S. Regulations: Current Good Manufacturing Practices in Manufacturing, Processing, Packaging, and Holding of Drugs	1
2	Finished Pharmaceuticals	13
3	Organization and Personnel	23
4	Buildings and Facilities	33
5	Equipment	53
6	Control of Components and Drug Product Containers and Closures	67
7	Production and Process Controls	85
8	Packaging and Labeling Control	112
9	Holding and Distribution	130
10	Laboratory Controls	134
11	Records and Reports	166
12	Returned and Salvaged Drug Products	191
13	Repackaging and Relabeling	194
14	The Inspection Procedure for Compliance in the United States: The Regulatee Is Inspected; The Rationale for Inspection	201
15	Recalls ad CGMPs: Enforcement Alternatives in the United States	243
16	Controlled Substances Safeguards	259
17	Who Is the Manufacturer? Some Additional Considerations for the Multinational	263
18	Bulk Pharmaceutical Chemicals	273
19	FDA Pre-Approval Inspections/Investigations	290
20	Other GMPs	295
21	Other Approaches to Quality	315
22	Import and Export of Pharmaceuticals and Other Products Subject to CGMPs	332
App. A	Potable Water Requirements	346
App. B	Components/Repackagers	355
App. C	Hearing Procedures When FDA Proposes the Imposition of Civil Money Penalties	410
App. D	Section 601.12 Changes Currently Considered "Important" by CBER	452
	Index	483