Quiz #1: Current GMP* Issues in the QC Laboratory
Answer each of the following questions with TRUE or FALSE.
Good luck!
- An out-of-specification (OOS) test result means that the product failed and must be rejected or reworked.
- An analyst obtaining an OOS result can investigate the OOS and release the product if an explanation is found
and the retest passes.
- If an OOS result is obtained, it is acceptable to repeat the test two more times and report the average of all results.
- Resampling (a new sample obtained and sent for testing) is rarely appropriate.
- Outlier testing alone may not be used to explain an OOS result for a physical or chemical test.
- OOS results caused by human error do not require a documented investigation.
- A firm may widen USP standard specifications if justified by statistical analysis of historical batch and control
data.
- Only non-compendial methodologies must be validated.
- GLP refers to the laboratory activity encountered in the quality control testing of in-process and finished
products.
- An OOS result can be explained as laboratory error and not necessarily considered a product failure.
*21 CFR Part 211 - Current Good Manufacturing Practices for Finished Pharmaceuticals
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