Manufacturing Standards (CGMP), Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF - 123KB)
FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations. This web page provides links to resources to help drug manufacturers comply with the Current Good Manufacturing Practice regulations.

Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
28 May 2012 Pharmaceutical Guidelines:ISO, FDA, USFDA, ICH, WHO, GMP, MHRA guideline, Validation Protocol, SO USFDA guidelines, GMP guidelines, WHO guidelines, Schedule M, FDA, European guidelines cleaning validation, process validation, water system validation, ICH guidelines, GMP audut
18 Jan 2018 Looking for FDA Guidance, Compliance, & Regulatory Information? Web page provides quick links to a variety of topics including nicotine-containing products, human drug compounding, and the Sunscreen Innovation Act.
FDA & ICH: Regulations and Standards for. Temperature-Controlled Supply Chains. The two greatest risks in pharmaceutical and biotechnology supply chains are the risk of product becoming adulterated during transport and the risk of non-compliance with federal regulations, guidelines and standards. After that the
The guidance is intended to provide recommendations to manufacturers who are implementing, or plan to implement, a quality systems model to help them comply with CGMP regulations. FDA regulatory and inspectional coverage will remain focused on the specific CGMP regulations.
14 Apr 2016 The recent influx of concerns over data manipulation and other data integrity questions in India, China and elsewhere has pushed the US Food and Drug Administration (FDA) to put out new draft guidance on Thursday to help the pharmaceutical industry ensure data is consistent and accurate.

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March 2018