Current good manufacturing practice regulations

Status of current good manufacturing practice regulations. 

Draft Guidance for Industry Quality System Approach to Pharmaceutical Current Good Manufacturing Practice Regulations. FDA, September 2004. 

GUIDANCE FOR INDUSTRY QUALITY SYSTEMS APPROACH TO PHARMACEUTICAL CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS... 

CFR 210.1 Status of current good manufacturing practice regulations... 

U.S. Food and Drug Administration (FDA) (2007), Current good manufacturing practice regulations, 21 CFR Parts 210 and 211, FDA, Rockville, MD. 

There are no records to document that the Information Technology (IT) service provider staff persormel have received training that includes current good manufacturing practice regulations and written procedures referred by the regulations. [FDA 483, 2000]... 

FDA (2002), Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals (21 CFR 211), revisions as of April 1. 

Process validation is a requirement of the FDA Current Good Manufacturing Practices Regulations for Finished Pharmaceuticals, 21 CFR Parts 210 and 211, and of the Good Manufacturing Practice Regulations for Medical Devices, 21 CFR Part 820, and therefore, is applicable to the manufacture of pharmaceuticals and medical devices intended for the United States. 

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