EMA Annex 2 VS USP 1207
EMA Annex 1 | USP 1207 |
| · Control aspects of Sterile Pharma Manufacture, including product containers and enclosures. | · Specific to container closure integrity (CCI). |
| · Less detail on methodology | · Most thorough guidance document of CCI to date. |
| · Statistically valid testing plan required based on QRM assessment. | · Provides detailed suggestions and approaches to identifying the appropriate test method. |
| · Automatic inspection methods should be validated to LOD equal to or better than manual inspection methods. | · Implying that scientific understanding of product requirements drives the decision process. |
| · A sterility test is only regarded as the last in a series of control measures to assure sterility. | · Introduces specific test methodology available for CCI. |
| · Coordinated effort by Pharmaceutical Inspection Cooperation Scheme (PIC/S) and the World Health Organization (WHO). | · Encourages use of deterministic methodologies. |
หากลูกค้าสนใจสินค้าเกี่ยวกับ EMA Annex 2 และ USP 1207 สามารถติดต่อเราได้ที่นี่
