• Q2 Analytical Validation

    Code Document Title Previously coded
    • Rapporteur :

      Dr. Yukio Hiyama (MHLW/PMDA, Japan)

      Regulatory Chair :

      Dr. David Keire (FDA, United States)

      Description :

      This topic was endorsed by the Assembly in June 2018.

      The Q2(R2)/Q14 EWG will develop a new ICH Quality Guideline, ICH Q14, on Analytical Procedure Development, and revise the ICH Q2(R1) Guideline on Validation of Analytical Procedures, with a view to potentially combine both documents into one, for simplification and clarity.

      Q2(R1) Revision

      The scope of the revision of ICH Q2(R1) will include validation principles that cover analytical use of spectroscopic or spectrometry data (e.g., NIR, Raman, NMR or MS) some of which often require multivariate statistical analyses. The guideline will continue to provide a general framework for the principles of analytical procedure validation applicable to products mostly in the scope of Q6A and Q6B.

      These proposed guidelines (Q2(R2) and Q14) are intended to complement ICH Q8 to Q12 Guidelines, as well as on-going ICH Q13 for Continuous Manufacturing.


      Q14 Analytical Procedure Development Guideline

      The new guideline is proposed to harmonise the scientific approaches of Analytical Procedure Development, and to provide the principles relating to the description of Analytical Procedure Development process. This new guideline is intended to improve regulatory communication between industry and regulators and facilitate more efficient, sound scientific and risk-based approval as well as post-approval change management of analytical procedures.

      Status :

      Step 1