Good Documentation in Pharmaceutical Industry (EuduraLex Vol- 4)

Good Documentation in Pharmaceutical Industry ( As Per EuduraLex Vol- 4) Principle Good documentation constitutes an essential part of the…

Continue Reading →

Why Stability Testing is So much Important?

Why Stability Testing is So much Important (Climatic Zone & Conditions)?   As per STABILITY TESTING OF NEW DRUG SUBSTANCES AND…

Continue Reading →

Pharmaceutical Quality System Elements & Change Management System (ICHQ10)

Pharmaceutical Quality System Elements & Change Management System As per ICH Q10 The elements described below might be, required in part…

Continue Reading →

MANAGEMENT RESPONSIBILITY & CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (ICH Q10)

MANAGEMENT RESPONSIBILITY & CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (ICH Q10) Leadership is essential to establish and maintain a…

Continue Reading →

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…

Continue Reading →

Pharmaceutical Quality System (ICH Q10)

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

Continue Reading →

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…

Continue Reading →

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…

Continue Reading →

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…

Continue Reading →

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…

Continue Reading →