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Industry Urged To Use ICH Q12 Protocols To Ease Post-Approval Changes For Analytical Methods

 
• By Joanne S. Eglovitch

Post-approval change management protocols could go a long way toward smoothing global rollout of analytical method changes, ICH Q12 expert says.

In a Modern Laboratory Two Scientists Conduct Experiments
Industry Urged To Adopt PACMPS For Analytical Method Changes • Source: Shutterstock

The pharmaceutical industry should take advantage of the provision for post-approval change management protocols in the International Council on Harmonization’s Q12 guideline to facilitate analytical procedure changes, a member of the guideline’s implementation working group told a 4 February USP meeting.

The protocols can be used to describe a general approach for changes to analytical procedures across multiple products and testing facilities, asserted the working group member, Pfizer Inc. senior...

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