Outsourcing and/or manufacturing of Active Pharmaceutical Ingredients (APIs) can present many challenges, whether it’s staying up to date with agency regulations, monitoring suppliers, or preparing for inspections by the U.S. FDA.
While the facilities and processes for producing APIs must meet the principles of GMP in the FD&C Act, only finished dosage forms are subject to 21 CFR. The standard for API manufacturing quality is ICH Q7, but because it is not US law, FDA cannot cite it in enforcement actions, making the inspection and enforcement landscape for APIs challenging to decipher.
Another issue is that many of the APIs used in U.S. drug manufacturing come from countries that are more difficult to inspect, and those inspection challenges have been exacerbated by the recent pandemic. With decreased visibility of the current state of quality systems at these facilities due to restrictions, how can we predict the current state of manufacturing at those facilities?
To help develop insights into issues and trends uncovered at API manufacturing sites, data scientists and industry quality experts at Redica Systems worked together to create models that identify and organize the key elements from API enforcement documents and map them to the FDA quality systems, allowing more granular analysis and comparison with finished dosage form inspection data.
You can review this data and uncover the trends for your team by downloading the webinar, Insights from Mapping API Inspection Deficiencies to the Quality Systems, presented by Senior GMP Quality Expert Jerry Chapman.
Jerry reviewed case studies showing the results of applying the models to API inspection data and the resulting insights and trends.
About the Speaker:
Jerry Chapman is a Senior GMP Quality Expert at Redica Systems. He writes the Redica Systems column “Conference Spotlight” and has worked with our data engineers to build machine learning models for analysis of agency enforcement documents – models we continue to refine and improve. He brings 40 years of experience in the pharma industry, including 31 years at Eli Lilly in technical and leadership positions in research and product development, manufacturing, plant quality, site quality, corporate quality, and quality systems.
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