On April 18-19, 2018, PQRI hosted a public Workshop: PQRI PODP Extractables & Leachables (E&L) Workshop. This was the official rollout and first full Workshop to explain and discuss the draft PQRI Safety Thresholds and Best Demonstrated Practices for Parenteral and Ophthalmic Drug Products (PODP).
WORKSHOP DESCRIPTION
The two-day event focused on the findings and outcomes of the PQRI PODP E&L work. Attendees learned:
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- How thresholds for parenteral products were derived
- Applicability of the thresholds to Small Volume Parenterals, Large Volume Parenterals, and Pre Filled Syringes
- Principles and concepts behind best demonstrated practices
- Extractable considerations for ophthalmic products
- Safety and quality concerns for biologics
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Attendees also learned about justifying study designs for extractable studies and assessing leachable safety.
FINAL PROGRAM
The final Workshop Program is available here.
PRESENTATIONS
Click here to access the presentations.
QUESTIONS
Please contact the PQRI Secretariat if you have any questions at +1(202) 230-5199 or PQRISecretariat@pqri.org.