REVIEW: GMP REQUIREMENTS ON DOCUMENTATION WITHIN PHARMACEUTICAL INDUSTRY

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.

KEYWORDS: - PMD, Specifications, Quality Assurance, Quality Control, Batch, SOP, Record.