How will the new ICH draft guidance (Q14) for Analytical Procedure Development impact Stability programs?
Brian Glass, senior analytical consultant of Pharmatech Associates has written an analysis, saying “Q14 describes an enhanced approach for method development, validation, and life cycle management. ICH Q2 was also updated to reflect the proposal in Q14: both are now available for public consideration and feedback, and both draft guidelines agree with the proposed USP <1220> chapter on analytical life cycle management. What’s new is that the enhanced approach described in Q14 employs elements of quality by design (QbD) and risk management tools and applies these to analytical procedures. While the enhanced approach is not mandatory, there are benefits to the methodology.”