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.
There shall be written procedures developed requiring sampling if microbial
contamination is suspected.
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.
Ga. Comp. R. & Regs.
Original Rule entitled
"Quality Assurance Program for Compounding and Preparation of Sterile
Pharmaceuticals" adopted. F. Apr. 19,
2004; eff. May 9, 2004.
New Rule of same title adopted. F. Nov. 22,
2006; eff. Dec. 12, 2006.