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Extractables studies are performed to plan the risk mitigation and to identify potential leachables from the product contact parts for the pharmaceutical dosage forms. The approach to toxicological safety evaluation of extractables and leachables to address the safety concern will depend on the formulation of the drug product, route of administration and the duration of administration to the patient. The workshop will enable the attendees, through case studies, to understand the approaches to safety evaluations by applying the concepts stepwise in the toxicological evaluation of individual extractables or leachables.
Key Takeaways:
At the end of the workshop the attendees will:
- be able to understand the extractable reports
- understand the risk assessment process flow including USP <1665> and BioPhorum guidance
- be able to make a toxicological safety evaluation for a formulation by a case study.
2022 PDA Aseptic Processing of Biopharmaceuticals Conference
The 2022 PDA Aseptic Processing of Biopharmaceuticals Conference will address topics related to the manufacturing of sterile drug products and patient-friendly applications. This year's conference will build up on last year's theme including topics involving challenges in isolators, glove leak testing, pre filled syringe installations, use of robotics in aseptic filling, and recent innovations in visual inspections. It will also introduce Industry 4.0 in Aseptic filling, advances in glass technologies and Quality in Biotherapy Production.
Our regulatory section will include the participation of MFDS, India and ex-US FDA inspectors providing Regulatory information about changes that will affect the pharmaceutical manufacturing environment and also how to manage regulatory inspections.
Simultaneous Interpretation/Translation (SI) English - Korean will be available
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