ความแตกต่างระหว่าง EMA Annex1 VS USP 1207

EMA Annex1

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.