◎ Regulatory requirements
1. Chinese GMP and EU EP have made specific provision for the integrity testing of sterile
filter on the test method, where the commonly used methods include bubble point test, diffusion
flow test or pressure holding test. GMP regulates that the test is required after the use of sterile
filtration. EP regulates that the test is required before and after the use, and at the same time EP
regulates that the critical gas and air filter must be confirmed after use, while other filters must be
tested on a regular basis.
2. According to Drug Manufacturing Quality Management Standard (revised in 2010) Article
310, two appendices of Computerized System and Confirmation and Validation are now issued,
as the supportive documents for Drug Manufacturing Quality Management Standard (revised in
2010), effective as of December 1, 2015.
3. The requirements for electronic records and electronic signatures as specified in 21 CFR