1. China “Good Manufacture Practice of Medical Products” (Revision 2010)
中国《药品生产质量管理规范》(2010版)
http://www.nmpa.gov.cn/WS04/CL2077/300569.html
2. China “Good Manufacture Practice of APIs” (Revision 2010)
中国《原料药GMP实施指南》(2010版)
3. ISO 14644 Cleanrooms and associated controlled environments
ISO14644“洁净室及相关受控环境” 要求
https://www.iso.org/search.html?q=ISO%2014644
4. ICH Q7a “Good Manufacture Practice Guide for Active Pharmaceutical Ingredients” FDA cGMP (Edition 2004)
ICHQ7A之美国FDA cGMP(2004)
https://www.gmp-compliance.org/guidelines/gmp-guidelines-download
5. EU EMEA GMP
欧盟EMEA GMP
https://www.gmp7.com/emea_cm320.html
6. EU GMP Annex 15: Qualification and Validation
欧盟 GMP Annex 15: Qualification and Validation
https://ec.europa.eu/health/documents/eudralex/vol-4_en
7. ISPE Good Practice Guide
ISPE 制药工程设计指南
https://ispe.org/initiatives/regulatory-resources/gmp/what-is-gmp#
8. PIC/S GMP Guide (July,2018)
PIC/S GMP 国际药品认证合作组织指南
https://www.picscheme.org/en/publications?tri=gmp#selSection_PIC/S GMP Guide