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
International Journal of Trend in Scientific Research and Development (IJTSRD)
Volume 5 Issue 6, September-October 2021 Available Online: www.ijtsrd.com e-ISSN: 2456 – 6470
@ IJTSRD | Unique Paper ID – IJTSRD47639 | Volume – 5 | Issue – 6 | Sep-Oct 2021
Page 1461
Good Manufacturing Practice (GMP)
Guidelines (Eudralex-Volume 4)
Mr. Rajesh. L. Dumpala
1
, Mrs. Lakshmi Prasuna. R. Dumpala
2
1Research Scientist, Department F. & D. (MS&T), Alembic Research Centre, Vadodara, Gujarat, India
2Assistant Professor, Department of Pharmacy, Sumandeep Vidyapeeth University, Vadodara, Gujarat, India
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.
KEY WORDS: GMP, 21 CFR, Part 210 and 211, Documentation,
Regulations Agencies
How to cite this paper: 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,
pp.1461-1472,
URL:
www.ijtsrd.com/papers/ijtsrd47639.pdf
Copyright © 2021 by author (s) and
International Journal of Trend in
Scientific Research and Development
Journal. This is an
Open Access article
distributed under the
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the Creative Commons
Attribution License (CC BY 4.0)
(http://creativecommons.org/licenses/by/4.0)
HISTORY OF GMP
US patented