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Edited By Graham P. Bunn
This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.
Chapter 1. Status and Applicability of U.S. Regulations CGMP
By Graham P. Bunn
The Food and Drug Administration (FDA) is responsible for ensuring the quality of drug products by carefully monitoring drug manufacturers’ compliance with Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have. FDA’s portion of the CFR is in Title 21, which interprets the Federal Food, Drug and Cosmetic Act (FD&C Act) and related statutes, including the Public Health Service Act.
Chapter 23. Worldwide Good Manufacturing Practices
By Dominic Parry
There are various different types of good manufacturing practice (GMP) across the world. All aim to do essentially the same thing: to protect the end user from poor quality of medicines. This chapter provides an overview of some of the main GMP standards outside of the United States. As such, we will cover the following:
GMP in the European Union
GMP in Japan
The Pharmaceutical Inspection Co-operation Scheme GMP (PIC/S GMP)
World Health Organization GMP (WHO GMP)
GMP for Active Pharmaceutical Ingredients