Which standards and regulations apply?

EU GMP Guide – Annex 1 “Manufacture of Sterile Medicinal Products”

The EU GMP Guide (EudraLex, Volume 4, Annex 1) requires that the integrity of a sterilized filtration system is verified prior to sterile filling operations.

US FDA Guidance – Aseptic Processing

While the FDA does not explicitly require a mandatory pre-use integrity test as defined in EU GMP regulations, it recommends performing filter integrity testing after filtration or installation, as well as at appropriate stages of the process, to ensure the early detection of leaks or damage.

FDA 21 CFR Part 11 – Audit Trail Requirements

21 CFR Part 11 governs the use of electronic records and electronic signatures in the pharmaceutical and biotechnology industries. It requires a secure, computer-generated audit trail that automatically records all GMP-relevant actions and data changes in a complete, tamper-evident, and fully traceable manner.