Good Documentation in Pharmaceutical Industry ( As Per EuduraLex Vol- 4) Principle Good documentation constitutes an essential part of the…
Why Stability Testing is So much Important (Climatic Zone & Conditions)? As per STABILITY TESTING OF NEW DRUG SUBSTANCES AND…
Pharmaceutical Quality System Elements & Change Management System As per ICH Q10 The elements described below might be, required in part…
MANAGEMENT RESPONSIBILITY & CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (ICH Q10) Leadership is essential to establish and maintain a…
ICH Requirements For Quality manual, Management commitment,Quality Planning & Quality policy (Pharmaceutical Quality System As Per ICH Q10) ICH Q10…
Pharmaceutical Quality System Guideline as per ICH Q10. Introduction This document establishes a new ICH tripartite guideline describing a…
SOP For Microbial Monitoring in Drain Point of Pharmaceutical Manufacturing sites. PROCEDURE: Carryout the microbiological testing of the drain…
Most Important Definitions In Clinical Trials. As Per ICH HARMONISED TRIPARTITE GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE – E6(R1) What is Clinical Trials? What…
What is the meaning of Sterility Test? Meaning of sterility test:- Sterility testing is set of activity to confirm that…
Before attending any QA&QC interviews be prepared for the below question – Answer QA&QC DEPARTMENT List of all questions…