Many of Pharmaceuticals organization received 483 due to selection of improper investigation tools.
For example, system suitability is not achieved (bracketing RSD failed) and investigation started through lab incident without ensuring the test results. The result is OOS, but considering first observation (RSD failure) laboratory iniciated investigation through Incident. FDA may consider this a major 483 for hiding a failure result.
Any non conformance of specification should be handled through OOS only.
If result is not OOS or OOT and system suitability parameters are failed, then only it should be handle through laboratory Incident.
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