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We humbly present you a complete Library of screened and compiled information regarding different regulations, laws and other useful information from the deemed regulatory authorities that help you for a quick revision to improvise your organizational compliance practices and strengthen your Systems in your areas of operation.

Computer System Validation(CSV)
from USFDA

Guidance of USFDA on Computer System Validation and General Principles of Software Validation.

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GAMP

A simplified and generalized GAMP 5 (Good Automated Manufacturing Practices) Approach from the Scientific Community.

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ICH quality guidelines

Quality matters the most. Take a look at the recent ICH guidelines regarding Stability Testing, Analytical Validation, Impurities,

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What 21 CFR Part 11 says…

Guidance for the industry from USFDA...

Level 2 Guidance - Laboratory Controls

Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance - Laboratory Controls

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WHO Guidelines - medicines and health products

WHO Guidelines on Essential medicines and health products

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WHO Guidelines (medicines and health products - Basic tests 1998)

WHO Guidelines on Essential medicines and health products - Basic tests for pharmaceutical dosage forms,1991

WHO Guidelines (medicines and health products - Basic tests 1991)

WHO Guidelines on Essential medicines and health products - Basic Tests for Drugs - Pharmaceutical Substances

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The Drugs and Cosmetics Act, 1940

The Drugs and Cosmetics Act, 1940


The Drugs and Cosmetics Act, 1940 - Amendment 2008

The Drugs and Cosmetics Act, 1940 - Amendment 2008

CENTRAL DRUGS STANDARD CONTROL ORGANIZATION

CENTRAL DRUGS STANDARD CONTROL ORGANIZATION

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