Category: Pharma Guidelines

PIC/S guide 0

PIC/S Guide- A Comprehensive Review

It contains History of PIC, PIC/S Guide, FAQs and List of PICs Members. History Of PIC/S Guide: In October 1970, the Pharmaceutical Inspection Convention (PIC) was established by the European Free Trade Association (EFTA)...

nitrosamine impurities 0

Nitrosamine Impurities – Information Guide

This article contains information about Nitrosamine impurities, its different types and mitigation plan to avoid presence of these impurities for pharmaceutical Drug substances and Drug products. What is mean by Nitrosamine Impurities for pharmaceutical...

ICH Guideline 0

ICH Guidelines- Quality

What Is mean by ICH Guidelines ? The International Council for Harmonisation has created a set of guidelines known as the ICH guidelines for the pharmaceutical industry. ICH is a global organization that brings...

DMF-Drug Master File 0

Drug Master File (DMF)

What is Mean by Drug Master File I/II : Introduction/ Description:  Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority...