CAG Announcement #7 as of October 4, 2022
CAG-003: Certification of Sterile Compounding Facilities for USP Compliance (Revised 2022) The new CAG-003 describes concepts and testing procedures applicable to cleanroom and sterile equipment testing and certification. Certification of sterile compounding facilities and equipment must be performed consistently and in a repeatable manner. The process should be well understood by the compounding facility and certification company. This guide, along with USP Chapters <797>, <800> and <825>, provide minimum acceptance criteria for many of the tests required for compliance to state board regulations and other regulatory bodies and provides industry best practices where possible. |
