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Quality-Control Analytical Methods: Common Concerns about Out-of-Specification Results
1Analytical Research Laboratories, Oklahoma City, Oklahoma.
International Journal of Pharmaceutical Compounding
|August 27, 2013
Summary
When potency testing results for compounded preparations are out-of-specification, this article investigates causes and solutions. It guides compounding pharmacists through troubleshooting unexpected results and implementing error-minimizing practices.
Area of Science:
- Pharmaceutical Compounding
- Quality Control
- Analytical Chemistry
Background:
- Potency testing is crucial for compounded preparations.
- Unexpected results raise concerns and necessitate investigation.
Purpose of the Study:
- To address common questions regarding out-of-specification (OOS) potency test results.
- To provide potential solutions and investigative processes for OOS results in compounding.
Main Methods:
- Defining "out-of-specification" and identifying responsible organizations.
- Explaining laboratory vs. compounded preparation OOS differences.
- Describing retesting procedures and potential causes/remedies.
Main Results:
- Outlines a systematic investigative process for OOS results.
- Provides actionable remedies and preventative strategies.
- Highlights the importance of readily available resources for compounding pharmacists.
Conclusions:
- Effective troubleshooting of OOS results is essential for patient safety.
- Implementing best practices can minimize compounding errors.
- Pharmacists should utilize provided resources for OOS result management.
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