DOCUMENT MANAGEMENT IN PHARMACEUTICAL INDUSTRY (KEY IJP************220)

• Aroon Adulapuram, Fariyah Nargis , G. Pallavi , G. Sangeetha

Abstract

The basic rules in any good manufacturing practice (GMP) regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records. Documentation helps to build up a detailed picture of what a manufacturing function has done in the past and what it is doing now and, thus, it provides a basis for planning what it is going to do in future. Regulatory inspectors, during their inspections of manufacturing sites, often spend much time examining a companys documents and records. Effective documentation enhances the visibility of the quality assurance system. Considering above facts, we have tried to harmonize different GMP requirements and prepare comprehensive GMP requirements related to documentation and records, followed by a meticulous review of the most influential and frequently referred regulations. IF ITS NOT WRITTEN DOWN,THEN IT DIDNT HAPPEN!