Out of Trend

Out of Specification &Out of Trend Investigations (MHRA)

Quality Control

Out of Specification &Out of Trend Investigations (MHRA) Laboratory Analysis Investigations of “Out of Specification (OOS) / Out of Trend (OOT)/ Atypical results” have to be done in cases of: Batch release testing and testing of starting materials. In-Process Control testing: if data is used for batch calculations/decisions and if in a dossier and on …

Out of Specification &Out of Trend Investigations (MHRA) Read More »

How to Investigate Out Of Specification(OOS) Test Results….???( USFDA Phase -I)

Uncategorized

How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -I) Out Of Specification(OOS) :-  The all test results which goes outside the specification or acceptance criteria established in Drug Dossiers, Drug Master files, Its official Pharmacopeias, Or the manufacturer comes Under Out of Specification(OOS).   What USFDA guideline says about Investigation of Out …

How to Investigate Out Of Specification(OOS) Test Results….???( USFDA Phase -I) Read More »