The ICH guidance document on Validation of Analytical Procedures, ICH Q2, has been updated to Q2(R2). A new ICH guidance document on Analytical Procedure Development, Q14, has been introduced. The combination of these two documents provides guidance on management of the analytical procedure lifecycle from initial development through to validation and post validation changes.
The aim of this short course is to fully explore the updates to Q2 in terms of: the additional information that has been introduced, and the expected benefits; the potential additional validation requirements and associated gap assessment, when compared to previous requirements; and also to provide an overview of the contents of Q14.
The course is suitable for anyone with a good understanding of the previous ICH Q2(R1) guidance who wants to learn about the proposed changes in ICH Q2(R2), and would also like to know about how the guidance works in combination with the new guidance on analytical procedure development, Q14.
This course is an ideal follow-up for those who have attended either of our training courses: ‘Validation, Verification and Transfer of Methods for Pharmaceutical Analysis‘; or ‘Validation, Verification and Transfer of Methods for Biopharmaceutical Analysis‘, prior to the finalisation of Q2(R2) and Q14 in November 2023.
The aim of this short course is to fully explore the updates to Q2 in terms of: the additional information that has been introduced, and the expected benefits; the potential additional validation requirements and associated gap assessment, when compared to previous requirements; and also to provide an overview of the contents of Q14.
The course is suitable for anyone with a good understanding of the previous ICH Q2(R1) guidance who wants to learn about the proposed changes in ICH Q2(R2), and would also like to know about how the guidance works in combination with the new guidance on analytical procedure development, Q14.
This course is an ideal follow-up for those who have attended either of our training courses: ‘Validation, Verification and Transfer of Methods for Pharmaceutical Analysis‘; or ‘Validation, Verification and Transfer of Methods for Biopharmaceutical Analysis‘, prior to the finalisation of Q2(R2) and Q14 in November 2023.
Learning Objectives
- Understand the proposed changes to ICH Q2 and their significance.
- Be aware of the key features of ICH Q14.
- Be able to implement the new requirements as appropriate.
