On this page you can find WHO compendium of guidelines, norms and standards that serve as a comprehensive guide, covering a broad spectrum of pharmaceutical products. While some of the relevant guidelines have been highlighted on this page, manufacturers are strongly advised to thoroughly review the entire set of guidelines to ensure a complete understanding of the context and requirements. Relying solely on specific documents or annexes without considering the full guideline may lead to gaps in ensuring product quality, safety, and compliance.
OVERARCHING GUIDELINES
GOOD MANUFACTURING PRACTISES (GMP)
- WHO GMP FOR PHARMACEUTICAL PRODUCTS: MAIN PRINCIPLES
- WHO GMP FOR EXCIPIENTS USED IN PHARMACEUTICAL PRODUCTS
- WHO GMP: WATER FOR PHARMACEUTICAL USE
- WHO GUIDELINES ON VARIATIONS TO A PREQUALIFIED PRODUCT
- WHO GUIDELINES ON QUALITY RISK MANAGEMENT
- WHO GUIDELINES ON HEATING, VENTILATION AND AIR-CONDITIONING SYSTEMS FOR NON-STERILE PHARMACEUTICAL PRODUCTS
GUIDELINES ON VALIDATION
Disclaimer: The information and documents provided are for general reference purposes only. Manufacturers are fully responsible for the safety, efficacy, and quality of their products throughout the entire product life cycle. Users are encouraged to consult the most current version of any referenced documents, as the versions available on this site may not reflect the latest updates. Compliance with the listed documents does not imply, guarantee, or ensure any business outcomes, approvals, or regulatory compliance.