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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

Related Categories: SOPs, QUALITY CONTROL, DOSAGE FORMS/DRUG CARRIERS

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