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)...
This article Includes List of Documents Required for Product Registration in WHO/UNICEF What are the WHO/UNICEF ? The World Health Organization (WHO) and United Nations Children’s Fund (UNICEF) have established prequalification programs for the...
This article Includes List of required documents for NDA Registration for drug product formulations. What is mean by NDA (New Drug Application)? A New drug application (NDA) is a request submitted to the United...
This article includes List of Documents Required for ANDA (Abbreviated New Drug Application) Registration. What is mean by ANDA ? ANDA stands for Abbreviated New Drug Application, which is a type of application submitted...
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...
This article provide information about 21 CFR Part 210 and Part 211. What is mean by CFR ? CFR stands for “Code of Federal Regulations.” It is a set of regulations, rules, and administrative...
This article contains information of orange book exclusivity codes with there definition. Orange Book – 21 Exclusivity codes with Definitions What is mean by Exclusivity? Exclusivity is a time period when a brand-name drug...
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...
This article contains information about Drugs and Cosmetics act 1940 (D&C act 1940) and Drugs and cosmetics rules 1945. Drugs and Cosmetics act 1940 (D&C act 1940) Â What is mean by Drugs and Cosmetics...
What is Mean by Drug Master File I/II : Introduction/Â Description:Â Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority...