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

Source:

https://database.ich.org/sites/default/files/ICH_Q2-R2_Document_Step2_Guideline_2022_0324.pdf

https://database.ich.org/sites/default/files/ICH_Q14_Document_Step2_Guideline_2022_0324.pdf

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