HOME     CONTACT     BACK

 
 
 
THE PHARMA REVIEW (SEPTEMBER - OCTOBER 2010)

A Validated RP-HPLC Method for Simultaneous Determination of 
International Documentation: The Essence for The Success of Pharmaceutical Industry

Saloni Kakkar, Jaimin Patel, Aakash Deep, Priyanka Phogat

Abstract
Documentation has now become a pillar for success of pharmaceutical industry. Not only it ensures compliance with regulatory authorities but also forms an essential part of quality management system. Though it may be a very complex and ambiguous process, efforts are being made at the international level to develop a simpler and harmonized process. In many countries of the world information relating to the API must be included in the registration document for medicinal product itself. However for registration in US, EU member states and other countries such as Australia, Canada and New Zealand the possibility exists for bulk manufacturers to file separate dossiers for API with authorities as supporting information to the registration of medicinal product. Good documentation also constitutes an essential part of the quality assurance system. Clearly written documents prevent error from spoken communication and permits tracing of batch history. The legibility of documents is of paramount importance. Properly documented actions provides important biological data for continuous quality improvement plan and are essential for any product that must meet regulatory requirement demanded by FDA and ISO and other quality systems.

 

For full text of this article contact the publisher on info@kppub.com

 

Go to Content Index Page

PHARMA REVIEW - ARTICLES ARCHIVE ( COMPLETE LIST)

The above content is an abstract only. For the full Article please contact:
KONGPOSH Publications Pvt. Ltd.
ICS House, C-19, Commercial Complex, SDA, Opp. IIT Gate, New Delhi, India -110016
Tel.: 26855839, 20057149, Fax: 91-11-26855876
Email: info@kppub.com / fpc@vsnl.com, Website: http://www.kppub.com

 
 
 

 Copyright 2008. KONGPOSH PUBLICATIONS Pvt. Ltd.