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Good Manufacturing Practices (GMP) are those that conform to guidelines recommended by relevant organizations. These agencies regulate the approval 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 ensure that their products are of consistently high quality from batch to batch for their intended use. The rules governing each industry can differ significantly; However, the main purpose of GMP is always to protect the end user from harm. Additional principles include ensuring that the end product is free of contamination, that it is consistent in its production, that its production is well documented, that personnel are well trained, and that the product is tested for quality beyond just the end stage. . GMP is usually ensured through the effective use of a quality management system (QMS). Good manufacturing practice guidelines provide guidelines for manufacturing, testing and quality assurance to ensure that a manufactured product is safe for human consumption or use. Many countries have legislated that manufacturers follow GMP procedures and developed their own GMP guidelines that correspond to their laws.
Good manufacturing practices are recommended to protect the health of consumers and patients as well as produce quality products. In the United States, a food or drug can be considered “adulterated” if it passes all specification tests but is manufactured in a facility or condition that violates or does not comply with current Good Manufacturing Practices.
Good manufacturing practice, good agricultural practice, good laboratory practice and good clinical practice are overseen by regulatory bodies in the UK, US, Canada, Europe, China, India and other countries.
All guidelines follow a few basic principles of GMP:
=>> Manufacturing facilities must maintain a clean and hygienic manufacturing area.
=>> Manufacturing facilities must maintain controlled environmental conditions to prevent cross-contamination from adulterants and allergens that could make the product unsafe for human consumption or use.
=>> The production process must be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
=>> The production process must be controlled, and any changes in the process must be evaluated. Changes affecting drug quality are verified as necessary.
=>> Instructions and procedures must be written in clear and unambiguous language using good documentation practices.
=>> Operators must be trained and document procedures
=>> Records must be created, manually or electronically, during production that show that all steps required by defined procedures and instructions were actually taken and that the quantity and quality of the food or drug was expected. Deviations must be investigated and documented.
=>> Production records (including distribution) that enable the complete history of a batch to be traced must be retained in an understandable and accessible form.
=>> Any distribution of products must minimize their quality risk.
=>> A system must be in place to withdraw any batch from sale or supply.
=>> Complaints about marketed products must be investigated, causes of quality defects must be investigated and appropriate measures taken to prevent recurrence of defective products.
