Section 61-06-01-08 - Quality controlThere must a documented, ongoing quality control program that monitors personnel performance, equipment, and facilities. The end product must be examined on a sampling basis as determined by the pharmacist-in-charge to assure that it meets required specifications.
1.Hood certification. All laminar flow hoods must be certified by federal standard 209B for operational efficiency at least every twelve months. Appropriate records must be maintained. 2.Prefilters. Prefilters for the clean air source must be replaced on a regular basis and these activities documented. 3.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. 4.Expiration dates. If the product is assigned a lengthy expiration date (anything exceeding ten 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. 5.Quality control audits. There must be documentation of quality assurance audits at regular, planned intervals. N.D. Admin Code 61-06-01-08
General Authority: NDCC 28-32-02
Law Implemented: NDCC 43-15-10(9), 43-15-10(12), 43-15-10(14)