Out Of Specification Investigation Phase II (MHRA) Conducted when the phase I investigations did not reveal an assignable laboratory error. …
Out of Specification &Out of Trend Investigations (MHRA) Laboratory Analysis Investigations of “Out of Specification (OOS) / Out of Trend…
SOP ON OPERATION AND CALIBRATION OF pH METER OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is to…
What is an Active Pharmaceutical Ingredient? “active pharmaceutical ingredient (API) Any substance or combination of substances used in a finished…
Why Stability Testing is So much Important (Climatic Zone & Conditions)? As per STABILITY TESTING OF NEW DRUG SUBSTANCES AND…
Before attending any QA&QC interviews be prepared for the below question – Answer QA&QC DEPARTMENT List of all questions…
Most Common Interview Questions For Regulatory Affairs Department. 1.What is Regulatory Affairs? Ans-Regulatory Affairs in a Pharmaceutical industry, is…
How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -I) Out Of Specification(OOS) :- The all test results…
What is Data Integrity In Pharmaceutical Industry…??? MHRA says,”The way regulatory data is generated has continued to evolve in line…