REVIEW: GMP REQUIREMENTS ON DOCUMENTATION WITHIN PHARMACEUTICAL INDUSTRY
Journal Title: Journal of Drug Discovery and Therapeutics - Year 2013, Vol 1, Issue 9
Abstract
Documentation within pharmaceutical industry is an essential part of both the Quality assurance and Quality control system. Documentation describes the specifications for all materials, methods of manufacturing and control. It will allow the personnel to decide whether or not to release batch for sale. And also to permit investigation of history of batch of product through tool of audit trails. The purpose of this work is to specify the GMP requirements on documentation within pharmaceutical industry. In this article firstly Processing of documents like (preparation, issue, use, storage, retrieval, retention, and disposal) and briefly information about the PMD is described. Secondly specification about key documents concerning Manufacturing, testing, packaging and other aspects like (distribution, complaints, and labels) are described.
Authors and Affiliations
Abhijeet Welankiwar*| Government College of Pharmacy Amravati (Maharashtra), 444604 India., Sushant Tope| Government College of Pharmacy Amravati (Maharashtra), 444604 India., Shrikant Saudagar| Government College of Pharmacy Amravati (Maharashtra), 444604 India., Ashwini Barabde| Government College of Pharmacy Amravati (Maharashtra), 444604 India., Gaurav Meshram| Government College of Pharmacy Amravati (Maharashtra), 444604 India., Hanuman Wable| Government College of Pharmacy Amravati (Maharashtra), 444604 India.
Keywords
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