Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS)
Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a manufactured product is safe for human consumption or use. Many countries have legislated that manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.
All guideline follows a few basic principles:
BS EN ISO 15378:2017 – TC. Tracked Changes. Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP).
BS EN ISO 15378:2017. Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP).
16/30347647 DC. BS EN ISO 15378. Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP).
BS EN ISO 15378:2015. Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to Good Manufacturing Practice (GMP).
BS EN ISO 15378:2011. Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to Good Manufacturing Practice (GMP).
BS EN ISO 22716:2007. Cosmetics. Good Manufacturing Practices (GMP). Guidelines on Good Manufacturing Practices.
BS EN ISO 15378:2007. Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to Good Manufacturing Practice (GMP).
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