Pharma GMP News of the Week: 3-April-2022

Period: March 27, 2022 to April 02, 2022

News from ICH: The draft of ICH Q2(R2) and Q14 reaches at Step 2 process

Date of News: March 31, 2022

Revision of ICH Q2(R2) and Q14 reached to Step 2 of the process on March 24, 2022. At this stage, it enters at public consultation stage.

The guidance included following main topics:

Analytical use of spectroscopic or spectrometry data such as Raman, NIR, MS, or NMR, with multivariate statistical analyses.
Draft ICH Q2(R2) and ICH Q14 will complement guidelines ICH Q8 to ICH Q13.

Q2(R2) – Draft version of Validation of Analytical Procedures and Q14 Analytical Procedure Development draft version endorsed on March 24, 2022

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