Certification topic
Good manufacturing practice
Purpose of GMP
Good manufacturing practice aims to ensure consistent manufacture and control under suitable conditions. The specific rules depend on the product type and the regulator or scheme that applies.
What an audit examines
Typical review areas include facilities, trained personnel, material controls, process instructions, batch records, equipment maintenance, sanitation, testing, deviations and corrective actions.
Scope matters
A GMP certificate should state the site, activities and scheme assessed. A private GMP or WHO-GMP-labelled certificate should not be read as regulatory licensing or World Health Organization endorsement unless such recognition is independently documented.
Assessment areas
- Premises, people and hygiene
- Materials, production and batch records
- Quality review and corrective action
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