Good Pharmaceutical Manufacturing Practice: Rationale and Compliance
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.
1133036050
Good Pharmaceutical Manufacturing Practice: Rationale and Compliance
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.
84.99 In Stock
Good Pharmaceutical Manufacturing Practice: Rationale and Compliance

Good Pharmaceutical Manufacturing Practice: Rationale and Compliance

by John Sharp
Good Pharmaceutical Manufacturing Practice: Rationale and Compliance

Good Pharmaceutical Manufacturing Practice: Rationale and Compliance

by John Sharp

Paperback

$84.99 
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Overview

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.

Product Details

ISBN-13: 9780367393779
Publisher: Taylor & Francis
Publication date: 09/23/2019
Pages: 520
Product dimensions: 7.00(w) x 10.00(h) x (d)

Table of Contents

Chapter 1 Introduction: Status and Applicability of US Regulations/EU Guidelines - General Quality Issues 1

Chapter 2 Personnel, Organization, and Training 19

Chapter 3 Premises/Buildings and Facilities 59

Chapter 4 Contamination and Contamination Control 85

Chapter 5 Equipment 99

Chapter 6 Materials Control 113

Chapter 7 Production and Process Controls 149

Chapter 8 Packaging and Labeling Control 171

Chapter 9 Holding and Distribution 191

Chapter 10 Laboratory Controls 211

Chapter 11 Records and Reports 253

Chapter 12 Returned and Salvaged Drug Products 325

Chapter 13 Sterile Products Manufacture - Basic Principles 329

Chapter 14 GMP and Quality Assurance in Sterile Products Manufacture 371

Chapter 15 Validation - General Principles 405

Chapter 16 Validation - Applications 439

Chapter 17 Self-Inspection and Quality Audit 469

Chapter 18 US cGMPs and EC GMP Guide - Concluding Comparison 485

Index 491

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