Can you please write one paragraph each?
1) GMP Production Environment
The Quality Control department for a biopharmaceutical company performs a test method (assay) for purity using a method called High Performance Liquid Chromatography (HPLC). The assay had been demonstrated to be suitable for use from the validation work. However, recently, the QC lab has generated a number of invalid assays. Thus, the test results cannot be accepted. How do you think an investigation into the problem should proceed? The assays were invalid because the assay control is not passing the established acceptance criteria.
2) Quality Management Systems
A test result from a Quality Control method generated an Out of Specification (OOS) result. During the Phase 1 investigation of the OOS result, it was discovered that the QC analyst who performed the test did not closely follow the Standard Operating Procedure (SOP) that describes the steps of the test. During the preparation work as described in the SOP, the analyst did not dilute the samples as specified in the SOP.
Discuss what steps should be taken after this outcome of the Phase 1 investigation.
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