Post Approval Changes for Analytical Methods in Regulated Labs

PROGRAM
SUMMARY:

Regulated laboratories
often struggle with restrictions associated with ‘registered analytical
procedures’ or methods. Despite encouraging a culture of continuous
improvements, regulatory affairs groups are often reluctant to address the
burden and cost of gathering pre-approval from regulatory health authorities
for changes, even when these offer clear robustness improvements, or offer
significant laboratory cost savings.

The ICH
harmonization group issued a Qualit…

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