Tag: EUDRALEX

Revision of the EU GMP Guide: EU Commission Proposal for Chapter 6 - Quality Control

https://seetharamkandarpa.webnode.in/news/revision-of-the-eu-gmp-guide-eu-commission-proposal-for-chapter-6-quality-control/

Handling of APIs and Excipients - New Guidelines in Chapter 5 of EU GMP Guide

https://seetharamkandarpa.webnode.in/news/handling-of-apis-and-excipients-new-guidelines-in-chapter-5-of-eu-gmp-guide/

EMA issues Draft Guideline on Similar Biological Medicinal Products for public consultation

https://seetharamkandarpa.webnode.in/news/ema-issues-draft-guideline-on-similar-biological-medicinal-products-for-public-consultation/

EU-GMP: New Annex 16 released

https://seetharamkandarpa.webnode.in/news/eu-gmp-new-annex-16-released/

EU-GMP Guide: final Chapter 2 on Personnel published

https://seetharamkandarpa.webnode.in/news/eu-gmp-guide-final-chapter-2-on-personnel-published/

Dun and Bradstreet Verification in the EU Site Master File?

https://seetharamkandarpa.webnode.in/news/dun-and-bradstreet-verification-in-the-eu-site-master-file-/

Guidelines on GDP (EU) revised

https://seetharamkandarpa.webnode.in/news/guidelines-on-gdp-eu-revised/

Summary of the new EU GMP Chapters and Annexes

https://seetharamkandarpa.webnode.in/news/summary-of-the-new-eu-gmp-chapters-and-annexes/

Draft EU GMP Annex 15 for Qualification and Validation published

https://seetharamkandarpa.webnode.in/news/draft-eu-gmp-annex-15-for-qualification-and-validation-published/

EudraLex V30 - January 2015

https://seetharamkandarpa.webnode.in/news/eudralex-v30-january-2015/

Update of Guideline on the packaging information of medicinal products for human use authorised by the Union (July 2015) [EudraLex - Volume 2]

https://seetharamkandarpa.webnode.in/news/update-of-guideline-on-the-packaging-information-of-medicinal-products-for-human-use-authorised-by-the-union-july-2015-eudralex-volume-2/

cGMP Guidelines

https://seetharamkandarpa.webnode.in/products/product-1/