GMP Inspections

Basics for Beginners

By:

Brendan Cooper

Format:

Paperback / softback

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Description

At over 400 pages, this book introduces the area of Good manufacturing and compliance for Regulated industries (Medical devices, pharmaceuticals and Biotechnology). The opening chapter covers the basics- principles of GMP, how it applies to people, equipment, materials and processes. This is then followed with chapters outlining the key themes and areas that arise within the various industries or specialties. While many GMP requirements apply to all medical and medicinal products, some area's exhibit additional requirements and focus points when it comes to audits and GMP inspections. Each chapter is clear, concise and draws heavily on published guidance from the FDA and other regulatory bodies. This results in a well structured summary or road map that details key topics and technical points subject to inspection. The following chapters are included: Introduction to Good Manufacturing Practices, Preparation for Audits, Inspection of Quality Systems, During the Inspection, Biotechnology Inspection Guide, Medical Device Inspection Guide, Sterile Drugs Inspection Guide, Computerised Systems Inspection Guide and Cleaning Inspection Guide.

Release date NZ

September 30th, 2017

Author

Brendan Cooper

Audience

General (US: Trade)

Pages

434

Dimensions

127x203x22

ISBN-13

9781548715328

Product ID

37359132

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