Good Manufacturing Practice (GMP)

Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance to ensure that a food or drug product is safe for human consumption.

All GMP guidelines follow a few basic principles:

  • Manufacturing facilities must maintain a clean and hygienic manufacturing area.
  • Cross contamination of food or drug product from adulterants, that may render the product unsafe for human consumption, must be prevented by controlling the environment
  • Manufacturing processes must be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
  • Manufacturing processes are controlled, and any changes to the process are validated. Changes that affect the quality of the drug are validated as necessary.
  • Instructions and procedures are written in clear and unambiguous language. Operators are trained to carry out and document procedures.
  • Cross contamination with unlabelled major allergens is prevented.
  • Records are made, manually or by instruments, 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 are investigated and documented.
  • Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
  • The distribution of the food or drugs minimizes any risk to their quality.
  • A system is available for recalling any batch from sale or supply.
  • Complaints about marketed products are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective products and to prevent recurrence.

 

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