What are GMPs?
Good manufacturing practices can apply to any industry as manufacturing, testing, and quality best practices that should be followed in order to produce safe products.
If you’re producing products where consumer-safety is especially important, or food, medical, or cosmetic items, following GMPs are an important way to assure quality and safety.
How about international GMPs?
Many regions have their own GMPs for food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices.
- WHO: GMP for pharmaceutical products (this is an international set of GMPs used by regulators in over 100 countries) – most of the national or regional GMPs are similar to this document.
- USA: They’re enforced under FDA Title 21 CFR.
- EU: The EU-GMP enforces standards for pharmaceutical products.
What do the practices include?
Let’s look at the WHO GMP as an example, since it is a kind of blueprint for others globally. In this case, it’s focused on pharmaceutical products, but you can see how this framework can be relevant for the manufacture of other safe product types, too.
GMP guidelines will be generally following these 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 documentation 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 were 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 a recurrence.
More content about good manufacturing practices
We’ve written about GMPs over on QualityInspection.org in these posts:
- Do Good Manufacturing Practices (GMP) Audits Drive Improvement?
- Understanding the Basics about Food GMP
- Food safety standards: ISO 22001, HACCP, GMP
You should also listen to our podcast episode about GMPs which covers what they are, how are they useful for importers with suppliers abroad in countries like China, what their relation is to controlling your suppliers in comparison to activities like quality audits, social compliance audits, and process audits, and more:
