Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control from Manufacturer to Consumer: Fifth Edition,

by Willig, Sidney H.

• ISBN13: 9780824704254
• ISBN10: 0824704258
• Format: Hardcover
• Copyright: 2000-10-12
• Publisher: Informa Healthc

Summary

Highlighting key issues and differences among GMPs of Europe, Canada, and the WHO, this reference examines US law and governmental policy affecting domestic and multinational pharmaceutical manufacturing. The book recommend pragmatic ways to interpret and comply with FDA CGMP regulation and related criteria. They focus on geographical redistribution of manufacturing facilities, accommodation of a diversity of regulatory and statutory governance, adaptation to disparate human resources, and new growth areas of manufacture and distribution of homeopathic remedies and dietary supplements, in addition to the greater quality control required of pharmacists and other authorized dispensers.

Author Biography

Sidney H. Willig is Professor Emeritus, Faculties of Law and the Health Sciences, Dentistry, and Pharmacy, Temple University, Philadelphia, Pennsylvania

Table of Contents

Preface	iii
Introduction	ix
Status and Applicability of U.S. Regulatins: Current Good Manufacturing Practices in Manufacturing, Processing, Packaging, and Holdings of Drugs	1	(15)
Finished Pharmaceuticals: General Provisions (Subpart A)	16	(14)
Organization and Personnel (Subpart B)	30	(13)
Buildings and Facilities (Subpart C)	43	(22)
Equipment (Subpart D)	65	(16)
Control of Components and Drug Product Containers and Closures (Subpart E)	81	(18)
Production and Process Controls (Subpart F)	99	(40)
Packaging and Labeling Controls (Subpart G)	139	(34)
Holding and Distribution (Subpart H)	173	(4)
Laboratory Controls (Subpart I)	177	(32)
Records and Reports (Subpart J)	209	(27)
Returned and Salvaged Drug Products (Subpart K)	236	(6)
Repacking and Relabeling	242	(14)
Bulk Pharmaceutical Chemicals	256	(17)
The Pharmacist and Total Quality Control	273	(28)
Recalls and CGMPs: Enforcement Alternatives in the United States	301	(16)
Controlled Substances Safeguards (21 CFR 1300, et seq.)	317	(4)
The Inspection Procedure for Compliance in the United States: The Regulatee Is Inspected; The Rationale for Inspection (21 USC 373, 374)	321	(46)
FDA Pre-Approval Inspections/Investigations; The Road from SUPAC to the Food and Drug Modernization Act	367	(12)
Who Is the Manufacturer? Some Additional Considerations for the Multinational	379	(10)
Other GMPs	389	(19)
Other Approaches to Quality	408	(17)
Import and Export of Pharmaceuticals and Other Products Subject to CGMPs	425	(13)
Enhancement of Global Product Distribution	438	(15)
Appendix A Food and Drug Modernization Act of 1997---in Pertinent Part	453	(95)
Appendix B Components/Repackagers	548	(65)
Appendix C Hearing Procedures When FDA Proposes the Imposition of Civil Money Penalties	613	(49)
Appendix D Section 601.12 Changes Currently Considered ``Important'' by CBER	662	(29)
Appendix E USP24--NF19 Information; Monographs; Tests; Assays	691	(28)
Index	719