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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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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: Loyd V. Allen, Jr., PhD, RPh, quality control, compounded sterile preparations, standard operating procedures, documentation and recordkeeping, quality assurance, process verification, procedure verification, analytical testing, microbiological testing, dosage forms


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