ความแตกต่างระหว่าง EMA Annex 2 VS USP 1207

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.

High-performance CCIT - 1µm

หากลูกค้าสนใจสินค้าเกี่ยวกับ EMA Annex 2 และ USP 1207 สามารถติดต่อเราได้ที่นี่


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