Ga. Comp. R. & Regs. R. 480-11-.09 - Quality Assurance Program for Compounding and Preparation of Sterile Pharmaceuticals

(1) There shall be a documented, ongoing quality assurance control program that monitors personnel performance, equipment, and facilities. Appropriate samples of finished preparations shall be examined to assure that the pharmacy is capable of consistently preparing sterile pharmaceuticals meeting specifications.

(a) All clean rooms, ante rooms, barrier isolators and laminar flow hoods shall be certified following procedures such as those outlined in the CETA Certification Guide for Sterile Compounding Facilities (CAG-003-2005) should be performed by a qualified individual no less than every six months whenever the device or room is relocated, altered, or major service to the facility is performed. Appropriate documentation and records shall be maintained.

(b) There shall be written procedures developed requiring sampling if microbial contamination is suspected.

(c) If bulk compounding of parenteral solutions is performed using non-sterile chemicals, extensive end preparation testing must be documented prior to the release of the preparation from quarantine. This process must include appropriate tests for particulate matter and testing for pyrogens.

(d) There shall be documentation of quality assurance audits at regular, planned intervals, including infection control and sterile technique audits.

Notes

Ga. Comp. R. & Regs. R. 480-11-.09

O.C.G.A. Secs. 26-4-4, 26-4-5, 26-4-27, 26-4-28, 26-4-86.

Original Rule entitled "Quality Assurance Program for Compounding and Preparation of Sterile Pharmaceuticals" adopted. F. Apr. 19, 2004; eff. May 9, 2004. Repealed: New Rule of same title adopted. F. Nov. 22, 2006; eff. Dec. 12, 2006.