Good Manufacturing Practices for Pharmaceuticals

Graham P. Bunn

ISBN: 9781041002499

Published: 25 May 2026

Format: Hardcover

Language: English

Publisher: CRC Press

Description

Good Manufacturing Practices for Pharmaceuticals is a practitioner-oriented guide to building and sustaining GMP-compliant operations across the pharmaceutical manufacturing lifecycle. Part of CRC Press's Drugs and the Pharmaceutical Sciences series, it addresses the regulatory frameworks, quality systems, and operational controls that manufacturers must implement to meet FDA, EMA, and international GMP expectations, translating regulatory requirements into practical shop-floor and quality-management guidance.

Key Features

- Structured guidance across the full GMP compliance lifecycle, from facility design to batch release
- Addresses FDA, EMA, and international regulatory expectations for pharmaceutical manufacturing
- Practical framing for quality management systems, documentation, and deviation handling
- Part of the established Drugs and the Pharmaceutical Sciences series from CRC Press

Coverage

Quality management systems, facility and equipment qualification, documentation and batch records, personnel training and hygiene, validation principles, deviation and CAPA management, and regulatory inspection readiness.

About the Author

Graham P. Bunn writes on pharmaceutical quality and manufacturing compliance, with this volume contributing to CRC Press's long-running Drugs and the Pharmaceutical Sciences series aimed at industry practitioners and regulatory science students.

Table of Contents

Organised around the GMP compliance lifecycle: (1) Regulatory Framework and Quality Systems, (2) Facilities, Equipment, and Personnel, (3) Documentation and Batch Records, (4) Validation and Change Control, (5) Deviation Management and Inspection Readiness.

Why buy this book?

For pharmaceutical manufacturing libraries, regulatory affairs departments, and quality assurance training programmes, this is a working reference for translating GMP regulation into day-to-day operational practice.

Keywords

good manufacturing practices, GMP, pharmaceutical manufacturing, quality assurance, regulatory compliance, FDA, EMA

Target Audience

Pharmaceutical quality assurance professionals, regulatory affairs teams, manufacturing compliance officers, pharmacy and pharmaceutical sciences libraries

Genre

Pharmaceutical Sciences, Regulatory Affairs, Quality Assurance, Professional Reference

AI-Optimized Q&A

Q: What are Good Manufacturing Practices (GMP) in pharmaceuticals?
A: GMP are the regulatory standards that ensure pharmaceutical products are consistently produced and controlled according to quality standards, covering facilities, personnel, documentation, and process validation.

Q: Which regulators enforce GMP compliance?
A: GMP compliance is enforced by agencies such as the U.S. FDA and the European Medicines Agency (EMA), alongside national regulators worldwide, based on harmonised international standards.

Q: What does a pharmaceutical quality management system typically cover?
A: It typically covers documentation control, deviation and CAPA management, equipment qualification, personnel training, and batch release procedures.

Q: Who uses GMP reference guides in practice?
A: Quality assurance professionals, regulatory affairs teams, and manufacturing compliance officers use GMP references for both operational guidance and inspection preparation.

Q: Where can I buy Good Manufacturing Practices for Pharmaceuticals?
A: This title is available directly from CLNZ Books, with worldwide shipping included in the price and secure payment by credit card or PayPal.

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