Module 9 2024

03/09/2024

Bioassays

ICH Q14: Analytical Procedure Development • Intends to improve regulatory communication between industry and regulators, facilitate more efficient, sound scientific and risk-based approvals as well as post-approval change management of analytical procedures. • The guidance presents a minimal approach versus an enhanced approach to analytical procedure development by bringing in elements from ICH Q8 Pharmaceutical Development and ICH Q9 Quality Risk Management. • The enhanced approach includes more documented evidence of thinking around: critical quality attributes (CQA); risk assessment of analytical methods; procedural controls and how to approach analytical procedure change after validation. • Compliments ICH Q2:Validation of Analytical Procedures, newly revised to ICH Q2(R2)

The Organisation for Professionals in Regulatory Affairs

35

35

Bioassays

The Organisation for Professionals in Regulatory Affairs

36

36

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