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