Ga. Comp. R. & Regs. R. 480-21-.08 - Quality Control

There shall be a documented, ongoing quality control program that monitors personnel performance, equipment, and facilities. The end product shall be examined on a sampling basis as determined by the pharmacist-in-charge to assure that it meets required specifications.

(a) Hood Certification. All laminar flow hoods shall be certified by Federal Standard 209B for operational efficiency at least every 12 months. Appropriate records shall be maintained.

(b) Prefilters. Prefilters for the clean air source shall be replaced on a regular basis and these activities shall be documented.

(c) End Product Sampling. There shall be written documentation that the end product has been tested on a sampling basis for microbial contamination.

(d) Bulk Compounding. If bulk compounding of parenteral solutions is performed utilizing nonsterile chemicals, extensive end product testing must be documented prior to the release of the product from quarantine. This process must include testing for sterility and pyrogens.

(e) Expiration Dates. If the product is assigned a lengthy expiration date (anything exceeding 10 days) there must be in-house data or data in the literature to assure the sterility and stability of the product at the time it is used by the patient.

(f) Quality Control Audits. There shall be documentation of quality assurance audits at regular, planned intervals.

Notes

Ga. Comp. R. & Regs. R. 480-21-.08

O.C.G.A. Secs. 16-13-73, 26-3-80, 26-4-27, 26-4-28, 26-4-60, 26-4-86, 26-4-87, 26-4-110, 26-4-111.

Original Rule entitled "Quality Control" was filed on August 30, 1985; effective September 19, 1985. Repealed: New Rule of same title adopted. F. Feb. 20, 2002; eff. Mar. 12, 2002.