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ICH M11 Guidance: Tech Spec - Clinical Electronic Structured Harmonised Protocol (CESHARP)
Recently on 21-December-2022, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled “M11...
Sharan Murugan
Dec 27, 20222 min read
ICH Guidance: Q3D(R2) ELEMENTAL IMPURITIES
Recently the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released the...
Sharan Murugan
Sep 17, 20221 min read
ICH Guidances: Q2(R2) Validation of Analytical Procedures, Q14, M12, E11A, E14 & S7B Updation
In an announcement yesterday, USFDA released the below draft guidances for industry, developed with the assistance of ICH, the...
Sharan Murugan
Aug 27, 20222 min read
ICH - Q9(R1) Quality Risk Management Draft Guidance Uupdation
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) It is commonly understood...
Sharan Murugan
Jun 18, 20222 min read
ICH-Draft Guideline on Pediatric Extrapolation & FInal Guidance on Considerations for Clinical Study
As part of its recent announcement, the International Council for Harmonization (ICH) released on 4 April 2022, a draft E11A guideline...
Sharan Murugan
Apr 10, 20222 min read
ICH's updated Draft Guidelines on Analytical Method Development
Two draft guidelines were issued by the International Council for Harmonization (ICH) on 31 March 2022 (Thursday), intended to support...
Sharan Murugan
Apr 4, 20221 min read
ICH guideline Recommendation on Daily (PDE) Limits for Seven Mutagenic Impurities
The International Council for Harmonization (ICH) Endorsed on 6 October 2021 its (Addendum to M7(R2)) M7(R2) draft guideline setting new...
Sharan Murugan
Oct 13, 20211 min read
ICH Q13 Draft Guideline reaches Step 2 of the ICH process
ICH on 27 July 2021, confirmed that the ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 2...
Sharan Murugan
Jul 28, 20211 min read