- REGISTRATION NOW OPEN: 4th PQRI/FDA Conference on Advancing Product Quality: Patient-Centric Product Design, Drug Development and Manufacturing April 9-11, 2019.
- PQRI’s Biopharmaceutical Technical Committee (BTC) launched a free quarterly webinar series presented by subject matter experts in the pharmaceutical sciences. This is a unique opportunity to learn about the latest research and regulatory trends on a variety of topics and interact with other experts in real-time all over the world without the need for travel.
- The third webinar in the series, Performance Testing in Quality Control and Product Development, Where are We? was held on October 23, 2018. To view a recording of the webinar, click here.
- The second webinar in the series, Questions about the Proposed Topical Classification System (TCS) and What To Do With It was held on Tuesday, June 19, 2018. To view a recording of the webinar, click here.
- The first webinar in the series, A Science Based Approach to Simplifying the Regulatory Pathway for Topical Drugs was held on Monday, April 9, 2018. To view a recording of the webinar, click here.
- On April 18-19, 2018 PQRI hosted a public Workshop: PQRI PODP Extractables and Leachables (E&L) Workshop. The Workshop 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). Click here to access presentations.
- The PQRI Stability Shelf Life Working Group Paper Evaluating Current Practices in Shelf Life Estimation has been published in AAPS PharmSciTech and is available at this link.
- The PQRI Solubility, Permeability Review Paper – Evolution of Choice of Solubility and Dissolution Media after Two Decades of Biopharmaceutical Classification System has been published in the AAPS Journal and is available at this link.
- On November 2-3, 2017, PQRI and USP hosted a public Workshop: PQRI/USP Workshop on ICH Q3D Elemental Impurities Requirements – Recent Experience and Plans for Full Implementation in 2018. Click here to access presentations.
- PQRI’s PODP Working Group’s paper Simulated Leaching (Migration) Study for a Model Container Closure System Applicable to Parenteral and Ophthalmic Drug Products (PODPs) has been published in the PDA Journal of Pharmaceutical Science and Technology. This publication is in support of the PODP WG’s forthcoming recommendations.
- On November 9-10, 2016, PQRI hosted a public Workshop: PQRI/USP Workshop on Implementation Status of ICH Q3D Elemental Impurities Requirements – Analytical and Risk Assessment Challenges. Click here to access presentations.
- On October 5 – 7, 2015, FDA and PQRI hosted a public conference “2nd FDA/PQRI Conference on Advancing Product Quality.” This Conference brought together regulatory, academic, and industry experts. Inputs from attendees will aid in future FDA guidance development. Click here to access the presentations. The report from the 2nd FDA/PQRI Conference has been published in The AAPS Journal, DOI 10.1208/s12248-016-9874-5.
- The PQRI BCS Class III Biowaiver Working Group recently published an article in Pharmaceutical Research.
- The Effect of Excipients on the Permeability of BCS Class III Compounds and Implications for Biowaivers. Parr, Alan; Hidalgo, Ismael J.; Bode, Chris; Brown, William; Yazdanian, Mehran; Gonzalez, Mario A.; Sagawa, Kazuko; Miller, Kevin; Jiang, Wenlei; Stippler, Erika S., August 2015, Pharmaceutical Research.
PQRI in the news:
- Continuous Manufacturing is Driving More Focus on Excipient Fitness for Purpose
Apr 17, 2017
International Pharmaceutical Quality (IPQ)
- Building Consensus for E&L Testing Standards
Mar 02, 2016
By Rita C. Peters
Volume 40, Issue 3, pg 46–48