ICH Requirement For Quality manual, Management commitment,Quality Planning & Quality policy (Pharmaceutical Quality System ICH Q10)

ICH Requirements For Quality manual, Management commitment,Quality Planning & Quality policy (Pharmaceutical Quality System As Per  ICH Q10) ICH Q10…

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Pharmaceutical Quality System (ICH Q10)

Pharmaceutical Quality System Guideline as per ICH Q10.    Introduction This document establishes a new ICH tripartite guideline describing a…

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SOP For Microbial Monitoring in Drain Point of Pharmaceutical Manufacturing sites.

  SOP For Microbial Monitoring in Drain Point of Pharmaceutical Manufacturing sites. PROCEDURE: Carryout the microbiological testing of the drain…

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Most Important Definitions In Clinical Trials.

Most Important Definitions In Clinical Trials. As Per ICH HARMONISED TRIPARTITE GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE – E6(R1)   What is Clinical Trials? What…

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What is the Meaning of Sterility Test?

What is the meaning of Sterility Test? Meaning of sterility test:- Sterility testing is set of activity to confirm that…

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Most Common Interview Questions For Quality Assurance & Quality Control Department.

  Before attending any QA&QC interviews be prepared for the below question – Answer QA&QC DEPARTMENT List of all questions…

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Most Common Interview Questions For Regulatory Affairs Department.

Most Common Interview Questions For Regulatory Affairs Department.   1.What is Regulatory Affairs? Ans-Regulatory Affairs in a Pharmaceutical industry, is…

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

How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -II) Out Of Specification( OOS ) :-  The all…

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

How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -I) Out Of Specification(OOS) :-  The all test results…

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What is Data Integrity In Pharmaceutical Industry…???

What is Data Integrity In Pharmaceutical Industry…??? MHRA says,”The way regulatory data is generated has continued to evolve in line…

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