Section 15.11. Quality assurance.

 

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

(2)  The area designated for preparing sterile pharmaceuticals and all horizontal and vertical laminar flow hoods shall be certified to be operationally efficient and meet the standards of a class 100 environment by an independent contractor. All biological safety cabinets shall be certified according to national sanitation foundations standard 49 or manufacturer's specifications. Certification shall take place before initial use or after relocation and at least annually. Certification records shall be maintained.

(3)  A pharmacy shall have written procedures requiring sampling for microbial contamination through a validation procedure, simulation of actual aseptic preparation, and by using bacterial growth medium to culture environmental samples.

(4)  If compounding of parenteral solutions is performed using non-sterile chemicals, extensive end-product sterility testing shall be documented. If any parenteral solution fails the testing, procedures shall be in place to quarantine future products for sterility testing to assure end-product sterility prior to release of the products from quarantine. The compounding process shall utilize components and techniques that assure a sterile and particulate-free product.

(5)  A pharmacy shall have written justification of the assigned expiration date for pharmacy prepared sterile pharmaceuticals.

(6)  A pharmacy shall have documentation of quality assurance audits, including infection control and sterile technique audits at least annually.

(7)  A pharmacy shall have procedures to assure consistent preparation of sterile pharmaceuticals.

History: Cr. Register, March, 2000, No. 531 , eff. 4-1-00.

Note

"National Sanitation Foundations Standard 49" refers to National Sanitation Foundation standard no 49 for class II (laminar flow) biohazard cabinetry / as prepared by the NSF Advisory Committee on Biohazard Cabinetry; and recommended for adoption by the NSF Council of Public Health Consultants by the National Sanitation Foundation (U.S.) published in 1983 by the National Sanitation Foundation of Ann Arbor, Michigan. Microsoft Windows NT 6.1.7601 Service Pack 1