GMP

What is GMP?

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)

GMP Guidelines

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:

  • Manufacturing facilities must maintain a clean and hygienic manufacturing area.
  • Manufacturing facilities must maintain controlled environmental conditions in order to prevent cross contamination from adulterants and allergens that may render the product unsafe for human consumption or use.
  • Manufacturing processes must be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
  • Manufacturing processes must be controlled, and any changes to the process must be evaluated. Changes that affect the quality of the drug are validated as necessary.
  • Instructions and procedures must be written in clear and unambiguous language using good documented practices.
  • Operators must be trained to carry out and document procedures.
  • Records must be made, manually or electronically, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations must be investigated and documented.
  • Records of manufacture (including distribution) that enable the complete history of a batch to be traced must be retained in a comprehensible and accessible form.
  • Any distribution of products must minimize any risk to their quality.
  • A system must be in place for recalling any batch from sale or supply.
  • Complaints about marketed products must be examined, the causes of quality defects must be investigated, and appropriate measures must be taken with respect to the defective products and to prevent recurrence.

GMP Standards

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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