GOOD MANUFACTURING PRACTICE - AN OVER VIEWJournal: Journal of Drug Sciences (Vol.1, No. 4)
Publication Date: 2013-11-24
Authors : P. Joshna Somasubra Ghosh M.Alagar Raja David Banji;
Page : 16-28
Keywords : Good manufacturing practices; Documentation and records; Quality assurance.;
The present study deals with the GMP guidelines. 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 the future. Effective documentation enhances the visibility of the quality assurance system. In light of above facts, we have made an attempt 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.
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