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FDA cGMP regulation requires the regulations document under Federal law.
21 Code of Federal Regulations Part 211.
Current Good Manufacturing Practice for Finished Pharmaceuticals.
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21 Code of Federal Regulation Part 211 covers:
WHO GMP covers:
In US, the Food and Drug Administration (FDA) regulates pharmacueticals quality in accordance with cGMP (current Good Manufacturing Practices). cGMP is a law. According to FDA, cGMP assures 'the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.
In Europe, the principles and guidelines of good manufacturing practices (GMP) for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC.
The basic requirements for GMP in Europe:
According to WHO, GMP is the part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate to their intended use and as required by the marketing authorization, clinical trial authorization or product specification. GMP is concerned with both production and QC. GMP is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products.
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According to TGA, Good Manufacturing Practice (GMP) describes a set of principles and procedures that when followed helps ensure that therapeutic goods are of high quality.
The ICH GMP is a guidance, described under ICH Q7 document called GMP Guidance for Active Pharmaceutical Ingredients. This Q7 GMP Guidance contains the requirements for GMP manufacturing. The US, EU and Japan follow this GMP Guide.
Reference:
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ICH(2015). 'Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients' from, http://www.ich.org/products/guidelines/quality/quality-single/article/good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.html
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Ng, R. (2005). Good Manufacturing Practice: Regulatory Requirements. Drugs, John Wiley & Sons, Inc.: 211-246.
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FDA (2015). "CFR-Code of Federal Regulations Title 21." from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211.
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Comission, E. (2015). "Eudralex-Volume 4 Good Manufacturing Practice (GMP) Guidelines." from http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm.
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Organization, W. H. (2015). "Essential medicines and health productTGA, T. G. A. (2015). "Manufacturing principles for medicinal products." from https://www.tga.gov.au/publication/manufacturing-principles-medicinal-products.s."
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pmda, 'GMP' available from https://www.pmda.go.jp/english/review-services/gmp-qms-gctp/0001.html
