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21 Code of Federal Regulations Parts 210 and 211- Current Good Manufacturing Practice Regulations
DESCRIPTION
The Current Good Manufacturing Practice (CGMP) Regulations, 21 Code of Federal Regulations Part 210 and 211, are Federal regulations which describe the minimum current good manufacturing practices for the preparation of drugs and drug products for administration to humans and animals. They include methods to be used in and the facilities or controls to be used for the manufacturing, processing, packing, or holding of a drug to assure that such drug meets the requirements of the Food Drug and Cosmetic act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.
21 CFR sections 210 and 211 still are the foundation of current industry practice with respect to manufacture of drug and drug product. Moreover, within these regulations are sections specifically relating to laboratory controls, and remain a document with which laboratory personnel need to maintain some familiarity.
INTENDED AUDIENCE AND USE
The CGMP regulations are made available in this pocket guide form for ease of reference by all laboratory personnel, management, and quality assurance staff. It should be noted, however, that the CGMPs are law, which is subject to change, and one should therefore refer to the actual regulations from time to time in order to stay current. The current version of the CGMPs is accessible through the FDA website www.fda.gov.
CONTENTS
[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
Adapted in pocket guide format.
COST
“21 Code of Federal Regulations Parts 210 and 211- Current Good Manufacturing Practice Regulations” is a 64 page booklet available for $9.95 plus $3.00 for shipping and handling. Volume orders and discounts are available.
ORDERING INFORMATION
"21 Code of Federal Regulations Parts 210 and 211- Current Good Manufacturing Practice Regulations” is available for purchase on Delphi Analytical Services, Inc.’s website www.delphianalytical.com. Go to product purchase and choose either e-mail or fax purchase, or contact:
Marketing and Communications Department
Delphi Analytical Services, Inc.
P.O. Box 487
Indian Rocks Beach, FL 33785
Phone 727-642-0192
Fax 727-593-3595
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