Date Published:
Sun, 07/01/2001GMP for API manufacturers. See sections 2.22.9, 2.23.8, 5.4, 6.12, 12.1, 12.2, 12.3, 12.6, 13.11, and 13.13 for specific computer and validation requirements.
Download:
Eudralex Annex 18.pdfGMP for API manufacturers. See sections 2.22.9, 2.23.8, 5.4, 6.12, 12.1, 12.2, 12.3, 12.6, 13.11, and 13.13 for specific computer and validation requirements.