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This book presents Current Good Manufacturing Practice (CGMP) requirements as set forth by the FDA. Supplemented with a handy keyword index, it provides, in a pocket-sized format, the complete and unaltered text of CFR Part 820. The index at the end of the book helps readers find the exact section of the reg they need. The comb binding makes it easy to use and the 3 3/4 inch by 5 1/2 inch size makes it easy to take from the desk top to the shop floor. It is a cost-effective tool for use in documented GMP training programs, for suppliers and vendors who need to be FDA compliant, and technicians who must secure adherence to US FDA regulations.
The bestselling and most useful aid available for finding all references to FDA and DEA regulations, Interpharm Master Keyword Guide: 21 CFR Regulations of the Food and Drug Administration, is used in hundreds of active pharmaceuticals, pharmaceutical, biotechnology, diagnostic, and device manufacturing companies. And it is in use by every FDA district in the United States to sort their way through their own regulations. Each of the over 20,000 entries is quoted in context to provide instant access to every noun, phrase, and concept used by the DEA and FDA. The KEYWORD and SECTION TITLE are sh.
The bestselling and most useful aid available for finding all references to FDA and DEA regulations, Interpharm Master Keyword Guide: 21 CFR Regulations of the Food and Drug Administration, is used in hundreds of active pharmaceuticals, pharmaceutical, biotechnology, diagnostic, and device manufacturing companies. And it is in use by every FDA district in the United States to sort their way through their own regulations. Each of the over 20,000 entries is quoted in context to provide instant access to every noun, phrase, and concept used by the DEA and FDA. The KEYWORD and SECTION TITLE are sh.
This guide contains over 20,000 entries completely cross-indexed and quoted in context to provide readers with instant access to every noun, phrase, and concept used by the Drug Enforcement Administration and U.S. Food and Drug Administration.
Supplemented with a handy keyword index, the Compact Regs series provides pocket-sized format (3 3/4 inch x 5 1/2 inch) verbatim reproductions of key US FDA regulations. The text is complete and has not been altered in any manner from the original source. Compact Regs Parts 110 and 111 covers good manufacturing practices for acid foods and batters. It describes prepackaging heat treatment of foodstuffs for a sufficient time and at a sufficient temperature to partially or completely inactivate the naturally occurring enzymes and effect other physical or biochemical changes in the food. It covers critical control points in a food process where there is a high probability that improper control ...
This publication contains a verbatim reproduction of 21 CFR Part 50 Protection of Human Subjects, 21 CFR Part 54 Financial Disclosure by Clinical Investigators, 21 CFR Part 56 Institutional Review Boards & 21 CFR Part 312 Investigational New Drug Application.
This guide contains over 20,000 entries completely cross-indexed and quoted in context to provide readers with instant access to every noun, phrase, and concept used by the Drug Enforcement Administration and U.S. Food and Drug Administration.
Supplemented with a convenient keyword index, this book provides a pocket-sized verbatim reproduction of key US FDA regulations. It presents the requirements as set forth by the FDA CFR 21 Parts 807, 812, and 814 to sell or distribute medical devices, including the pre-market approval requirements for the devices. The easy-to-use format that puts the exact section of the reg required by medical device manufacturers within easy reach. This is the perfect low-cost tool for employees as part of documented training programs; suppliers/vendors so that they may provide components, labels, and parts with an understanding of FDA requirements; and technicians charged with ensuring adherence to US FDA regulations.