In November 2023 ICH released the Step 4 documents for both ICH Q14 - Analytical Procedure Development and ICH Q2(R2) – Validation of Analytical Procedures. The two documents were developed in parallel by an ICH Expert Working Group with the charter to develop a new quality guideline on Analytical Procedure Development and to revise the ICH Q2(R1) Guideline on Validation of Analytical Procedures: Text and Methodology.

The objective of the ICH Q14 document was to harmonize the scientific approaches of analytical procedure development and provide the principles relating to the description of the analytical procedure development process. The document 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. In parallel, ICH Q2 (R2) includes 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, as well as continues to provide a general framework for the principles of analytical procedure validation applicable to products mostly in the scope of Q6A and Q6B.

A key driver for these documents was the need to encompass validation and procedure development principles for technologies lacking reference standards (e.g., NIR, MS, NMR). Issues regarding real-time release testing and multivariate analysis are called out specifically. This comprehensive presentation focuses on ICH Q14 - Analytical Procedure Development.

Learning Benefits

• History, purpose, scope, and objective of ICH Q14
• General considerations (minimal and enhanced approaches, procedure lifecycle) Analytical target profile
• Knowledge and risk management
• Evaluation of robustness parameters
• Analytical procedure control strategy
• Lifecycle management and post-approval changes
• Additional considerations: multivariable procedures and real time release testing
• Submission of analytical procedures and related information
• A brief discussion of the Annexes

Who Should Attend

The following individuals or disciplines will benefit from attending this webinar:

• Quality Assurance Personnel
• Quality Control Personnel
• Regulatory Compliance Managers
• Analytical Chemists
• Laboratory Management
• Chemical Manufacturing and Control (CMC) Personnel