Pharma Official Says Having Employee Buy-In Key to Improving Quality
This article was originally published in The Gold Sheet
Executive Summary
Pharma industry officials say that having strong employee buy-in is a key ingredient to improve manufacturing quality and decrease variability. An official from Eli Lilly offers a case study on how this approach helped them improve the bottom line.
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.