By Terry Jacobs, Andrew A. Signore
This revised e-book serves as a convenient and present reference for pros engaged in making plans, designing, construction, validating and keeping glossy cGMP pharmaceutical production amenities within the U.S. and the world over. the hot version expands on facility making plans, with a spotlight at the ever-growing have to adjust present legacy amenities, and on present developments in pharmaceutical production which come with innovations for sustainability and LEED construction rankings. All chapters were re-examined with a clean outlook on present solid layout practices.
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Extra resources for Good design practices for GMP pharmaceutical facilities
SUPPLY CHAIN LOGISTICS AND SECURITY The pharmaceutical industry relies heavily on a complex system of suppliers and distributors. Security and brand integrity are primary operating concerns. The Drug Supply Chain Security Act (initiated in January 2015) has set requirements for serialization and traceability to be implemented in three phases over a 10-year period. Traceability techniques are aimed at improving product integrity and reducing the counterfeiting through brand security measures, including microprinting, holograms, invisible inks, and other printing and mechanical methods.
Safe processing of cytotoxic materials presents considerable challenges to the manufacturer to ensure reliable protection for workers and the community. Delivering facilities that serve the global marketplace presents many risks and challenges to technical professionals. Diverse consumer preferences and regional business practices complicate the objectives to plan, design, construct, and operate cGMP facilities successfully. S. FDA, Medicine and Healthcare Products Regulatory (United Kingdom), Ministry of Health, Labor, and Welfare (Japan), China Food and Drug Administration, Central Drugs Standard Control Organization (India), and World Health Organization (United Nations), among others around the globe.
Commonly cited problems are contamination and inadequate testing of medications. The FDA has pledged to increase foreign facility inspections and to do so as frequently as it does domestic plants, which is every 2 years, according to the FDA Safety and Innovation Act of 2012. The agency also announced beefing up the number of inspectors it has in India from 12 to 19 and in China from 8 to 27. According to the FDA, approximately 40% of finished drugs come from abroad, and 80% of APIs are also manufactured outside the United States.