Good Manufacturing Practice GMP Guidelines Eudralex Volume 4
Journal: International Journal of Trend in Scientific Research and Development (Vol.5, No. 6)Publication Date: 2021-10-01
Authors : Rajesh. L. Dumpala Lakshmi Prasuna. R. Dumpala;
Page : 1461-1472
Keywords : GMP; 21 CFR; Part 210 and 211; Documentation; Regulations Agencies;
Abstract
The basic rules in any good manufacturing practice GMP regulations postulate that the pharmaceutical manufacturer must maintain appropriate documentation and records. Documentation helps to build up a detailed interpretation of what a manufacturing function has done in the past and what it is doing now and, thus, it provides a base for planning what it is going to do in the future. Regulatory evaluators, during their inspections of manufacturing sites, often devote much time on examining a company's documents and records. Effective documentation boosts the visibility of the quality assurance system. Mr. Rajesh. L. Dumpala | Mrs. Lakshmi Prasuna. R. Dumpala "Good Manufacturing Practice (GMP) Guidelines (Eudralex-Volume 4)" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-6 , October 2021, URL: https://www.ijtsrd.com/papers/ijtsrd47639.pdf Paper URL : https://www.ijtsrd.com/pharmacy/pharmaceutics/47639/good-manufacturing-practice-gmp-guidelines-eudralexvolume-4/mr-rajesh-l-dumpala
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