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Documentation: Records and Reports

Author(s):  Akers Michael J

Issue:  Sep/Oct 2017 - Volume 21, Number 5
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Abstract:  This article deals with documentation to include the beginning of documentation, the requirements of Good Manufacturing Practice reports and records, and the steps that can be taken to minimize Good Manufacturing Practice documentation problems. It is important to remember that documentation for 503a compounding involves the Formulation Record, Compounding Record, Standard Operating Procedures, Safety Data Sheets, etc. For 503b outsourcing facilities, compliance with Current Good Manufacturing Practices is required, so this article is applicable to them. For 503a pharmacies, one can see the development and modification of Good Manufacturing Practice and even observe changes as they are occurring in 503a documentation requirements and anticipate that changes will probably continue to occur.

Related Keywords: Michael J. Akers, PhD, Current Good Manufacturing Practice, U.S. GMP regulations, European GMP regulations, history of GMP regulations, sterile GMP regulations, CGMP, aseptic processing, sterile compounding, International Conference on Harmonisation, drug safety, pharmaceutical quality control, U.S. Food and Drug Administration, FDA, drug identity, drug strength, drug purity, drug quality, adverse events, compliance inspection, documentation practices, batch records, International Organization for Standardization, ISO, European Union, EU, Kefauver-Harris amendment, ICH, Pharmaceutical Quality System, PQS, ICH quality guidelines, ICH Q10


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