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Good Pharmaceutical Manufacturing Practice : Rationale and Compliance - John Sharp

Good Pharmaceutical Manufacturing Practice

Rationale and Compliance

Hardcover Published: 15th October 2004
ISBN: 9780849319945
Number Of Pages: 503

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With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced.
Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP guide, 2002). The author uses his 40+ years of experience in technical management, production, quality assurance, and distribution within the pharmaceutical industry, offering a hands-on guide to better understand and implement optimal pharmaceutical practices.
This book also compares the principle requirements of GMP, and explores the reasoning behind these requirements and ways to comply with them. Relevant topics include personnel, documentation, premises and equipment, production, quality control, self-inspection, recalls, and more. This is an essential guidebook for those who wish to expand their pharmaceutical business in any international capacity.

Introduction: Status and Applicability of US Regulations/EU Guidelines - General Quality Issuesp. 1
Personnel, Organization, and Trainingp. 19
Premises/Buildings and Facilitiesp. 59
Contamination and Contamination Controlp. 85
Equipmentp. 99
Materials Controlp. 113
Production and Process Controlsp. 149
Packaging and Labeling Controlp. 171
Holding and Distributionp. 191
Laboratory Controlsp. 211
Records and Reportsp. 253
Returned and Salvaged Drug Productsp. 325
Sterile Products Manufacture - Basic Principlesp. 329
GMP and Quality Assurance in Sterile Products Manufacturep. 371
Validation - General Principlesp. 405
Validation - Applicationsp. 439
Self-Inspection and Quality Auditp. 469
US cGMPs and EC GMP Guide - Concluding Comparisonp. 485
Indexp. 491
Table of Contents provided by Rittenhouse. All Rights Reserved.

ISBN: 9780849319945
ISBN-10: 0849319943
Audience: Professional
Format: Hardcover
Language: English
Number Of Pages: 503
Published: 15th October 2004
Publisher: CRC PR INC
Country of Publication: US
Dimensions (cm): 25.4 x 18.42  x 3.18
Weight (kg): 1.07
Edition Number: 1