cGMP updates

Current Good Manufacturing Practices (cGMP) pertain to regulations that are needed to ensure that the pharmaceutical product or medical devices comply with set standards.  CGMP updates are those updates that the regulatory agency, the FDA, keeps issuing from time to time to keep abreast of the developments that take place in the industry and its practices.

The FDA’s task

The task of issuing these cGMP guidelines, as well as ensuring that companies comply with them, belongs to the Food and Drug Administration (FDA). The common areas that require cGMP regulations relate to the methods, facilities, and controls used in not only manufacturing, but also processing and packing of a drug product.  These regulations ensure a twofold purpose: a) that a product is safe for use and b) that all the ingredients and strength it claims to have are actually contained in it.

Why issue updates?

Technologies, methodologies and practices keep changing from time to time. Since the FDA is the sole regulatory body for the pharmaceutical industry, it requires the industry’s practices to be both updated and current, meaning that its guidelines reflect the latest happenings on in the industry. It is to ensure that industry adapts the latest practices that cGMP updates are issued.

Prominent updates

The FDA has issued a few important cGMP updates. These are some of the important ones:

Current Good Manufacturing Practice for Finished Pharmaceuticals 21 CFR Part 211 (updated 4/1/2010)

  • Questions and Answers on Specific Topics
  • General Provisions (updated 4/30/2009)
  • Organization and Personnel
  • Buildings and Facilities (updated 3/12/2010)
  • Equipment (updated 5/18/2005)
  • Control of Components and Drug Product Containers and Closures (updated 7/5/2011)
  • Production and Process Controls (updated 12/20/2012)
  • Packaging and Labeling Control
  • Holding and Distribution (updated 8/9/2010)
  • Laboratory Controls (updated 7/12/2011)
  • Records and Reports (updated 7/19/2011)
  • Returned and Salvaged Drug Products (updated 6/24/2011)

References:

http://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm090016.htm

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124740.htm

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