Summary of Quality-Control Testing for Sterile and Nonsterile Compounded Preparations, Part 1: Physical and Chemical Testing
Author(s): Allen Loyd V Jr
Issue: May/Jun 2019 - Volume 23, Number 3
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Page(s): 211-216
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Abstract: Quality control and quality assurance are vital components for successful pharmaceutical compounding. A quality program consists of proper procedures, proper documentation, proper training, and proper testing, both analytical (physical and chemical) and microbiological. Each sterile and nonsterile dosage form has a number of tests that are appropriate and some that can be easily done. Some analytical tests can be conducted in-house and some may require outsourcing. All aspects of the quality program must be documented as well as periodically reviewed and updated. A quality program is constantly being changed and improved as new technology, equipment, and procedures are implemented in the facility. The end result of a quality program should be properly compounded preparations that are safe and effective for patients.
Related Keywords: quality control, compounded sterile preparations, standard operating procedures, documentation and recordkeeping, quality assurance, process verification, procedure verification, analytical testing, microbiological testing, dosage forms