Lessons from ISPE Quality Metrics Pilot: Start Small and Be Aware of Costs
This article was originally published in The Gold Sheet
Executive Summary
An ISPE report recommended FDA start with five well-understood metrics for its pharmaceutical quality metrics initiative and to add more later on. ISPE also says that though feasible, implementing a quality metrics program will be expensive, costing industry anywhere from $35 million to more than $100 million per year.
You may also be interested in...
Program Participants Urge The FDA To Adopt Some Pharmaceutical Quality Metrics And Avoid Others
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”
EU GMP Annex I Is A Top Priority For EMA While Industry Has Lingering Concerns
Questions about contamination control strategy raised as European Medicines Agency makes EU GMP Annex I revision a top priority in its 2021 work plan.
US FDA Mulls Advance Notice On Domestic Surveillance Inspections Post-COVID
Criticized for giving foreign sites advance notice of inspections, agency is considering giving such notice to domestic sites too even after surprise inspections become possible.