This Blog is created for the updation of knowledge on Quality Assurance, current Good Manufacturing Practices (cGMP) and current Updates from all regulatory authorities. Also one can archive Standard Operating Procedures (SOPs), specification and pharma jobs etc. for any Pharma plant.
The tripartite harmonised ICH guideline was finalised (Step 4) in November 2004. This guideline is intended to aid in planning pharmacovigilance activities, especially in preparation for the early postmarketing period of a new drug (in this guideline, the term "drug" denotes chemical entities, biotechnology-derived products, and vaccines). The main focus of this guideline is on a Safety Specification and Pharmacovigilance Plan that might be submitted at the time of licence application.