CAPA is a systematic process improvement to eliminate non-conformities. It requires organizations to rectify recurring manufacturing and documentation issues. Non-conformities can be customer complaints, machinery failures, or instruction errors
Volume 4 contains guidance on GMP principles for medicinal products. Replaced Directive 91/356/EC for investigational medicinal products. Replaced Directive 2003/94/EC for human medicinal products. Replaced Directive 2001/83/EC for human medicinal products
FSC is an official document issued by health authority in country of origin. Serves as evidence of legal manufacturing and marketing of cosmetic products. Ensures products meet safety and regulatory standards of exporting nation
FDA released updated ISO 10993 guidance in June 2016. New guidance includes additional FDA-recommended endpoints. ISO 10993-1 replaced previous version's device-specific endpoint list
All EU-market medicines manufacturers must comply with GMP. GMP ensures consistent quality and appropriate use of medicines. Manufacturers must register with national competent authorities
ICH Q10 is a comprehensive framework for pharmaceutical quality management. It combines GMP with ISO 9001 structure for modern pharmaceutical quality. It's an optional standard not mandated for market access