Bringing a Science-Based Approach to Regulation: The Story of the Product Quality Research Institute - Pharmaceutical Technology

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Bringing a Science-Based Approach to Regulation: The Story of the Product Quality Research Institute
The authors describe the development and organization of the Product Quality Research Institute and highlight some of the important projects conducted by its Working Groups.


Pharmaceutical Technology
Volume 33, Issue 12

References

(1) PQRI. "FDA's Commitment to PQRI." PQRI News, March 2002, page 2, http://www.pqri.org/newsletter/newsletter0302.pdf.

(2) PQRI Container Closure Working Group, "Basis for Using Moisture Vapor Transmission Rate Per Unit Product in The Evaluation of Moisture-Barrier Equivalence of Primary Packages for Solid Oral Dosage Forms" PQRI Whitepaper, September 2004 http://www.pqri.org/pdfs/whitepaper.pdf.

(3) PQRI Leachables and Extractables Working Group, "Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products", Submitted to FDA Sept. 8, 2006, http://www.pqri.org/pdfs/LE_Recommendations_to_FDA_09-29-06.pdf.

(4) D. Christopher et al., J. Aerosol Med. 16 (4), 235-247 (2003).

(5) J. Mitchell, J. Aerosol Med. 16 (4), 433 (2003).

(6) PQRI Mass Balance Working Group, "Mass Balance Proposal for FDA Guidance Document", submitted to FDA Oct. 26, 2006, http://pqri.org/pdfs/Mass_Balance_Submission_to_FDA_10_26_06.pdf.

(7) W.P. Adams et al., PharmSciTech . 8 (1), Article 4, 2007.

(8) D. Christopher et al., PharmSciTech . 8 (1), Article 5, 2007.

(9) D. Christopher et al., PharmSciTech . 8 (4). Article 90, 2007.

(10) PQRI Excipient Working Group, Pharm. Technol . 30 (9), 90-98 (2006).

(11) R. H. Seevers, "Report to FDA of PQRI RFID Working Group", submitted to FDA Dec 1, 2005, http://www.pqri.org/pdfs/RFID_Report_to_FDA_23Mar2006.pdf.

(12) PQRI Blend Uniformity Working Group, "The Use of Stratified Sampling of Blend and Dosage Units to Demonstrate Adequacy of Mix for Powder Blends", submitted to FDA Dec. 30, 2002. http://pqri.org/blenduniformity/imagespdfs/011003rec.pdf.

(13) G. Boehmet al., PDA J. of Pharm. Sci. and Technol., 57 (2), March/ April 2003, 64.

(14) "HPLC Column Classification" USP Pharmacopeial Forum 31 (2), Mar.-Apr. 2005, 637-645.

(15) L. Snyder et al., J. Chrom. A. 1057, 49-57 (2004).

(16) PQRI Specification and BACPAC Working Group, "Final Recommendation" submitted to the FDA June 2004.

(17) A. Teasdale et al., Org. Process Pre. Dev. 13 (3), 409 (2009).

(18) PQRI Stability Shelf Life Working Group: You can find a glossary, presentation slides and copies of posters at http://www.pqri.org/structure/wg.asp#sslwg.

(19) PQRI Aseptic Processing Working Group "Final Report" submitted to FDA Mar. 19, 2003, http://www.pqri.org/aseptic/imagespdfs/f inalreport.pdf.

(20) PQRI Post Approval Changes For Sterile Products Working Group Recommendations, submitted to FDA Apr. 19, 2007, http://www.pqri.org/pdfs/PAC_Final_Report_041907.pdf.

(21) PQRI Process Robustness Working Group, "Process Robustness" a PQRI Whitepaper, http://www.pqri.org/publications/index.asp.

(22) PQRI Risk Management Working Group, "Quality Risk Management Principles and Industry Case Studies", http://pqri.org/publications/index.asp

(23) S. Buchholz et al., PDA J. of Pharm. Sci. and Technol . 61 (3), 147-153 (2007).

(24) PQRI, "PQRI Achievements," Aug. 2007, http://www.pqri.org/pdfs/PQRI_ AccompBroPages.pdf.

(25) PQRI, "PQRI Contributors," PQRI News, Sept. 2002, page 14, http://www.pqri.org/newsletter/newsletter0902.pdf.

(26) FDA, Guidance for Industry, Powder Blends and Finished Dosage Units - Stratified In-Process Dosage Unit Sampling and Assessment (Rockville, MD, Oct. 2003).

(27) FDA "Concept Paper Regarding Aseptic Processing" to solicit early input prior to formal issuance of a draft guidance for public comment, Rockville, MD, Sept. 27, 2002.

(28) FDA, Guidance for Industry Sterile Drug Products Produced by Aseptic Processing (Rockville, MD, Sept. 2004).

(29) PQRI Leachables and Extractables Technical Team, "Leachables and Extractables Testing: Points to Consider." A response to the FDA draft Guidance for Industry: Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products Chemistry, Manufacturing, and Controls Documentation; and Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products Chemistry, Manufacturing, and Controls. Documentation ITFG/ IPAC-RS Collaboration, Mar. 27, 2001.

(30) Leachables and Extractables Working Group, "Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products," submitted to FDA Sept. 8, 2006.

(31) D. Ball et al., Toxicol. Sci., 97 (2), 226-236 (2007).

(32) D. L. Norwood et al., Pharm. Res., 25 (4), 727-739 (2008).

(33) European Medicines Agency, Committee for Medicinal Products for Human Use, Guideline on the Limits ofGenotoxic Impurities, effective Jan. 2007.

(34) Mueller et al., Reg. Toxicol. and Pharmacol. 44 (3), 198-211 (2006).

(35) FDA, Guidance for Industry "Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches, (Rockville, MD, Dec. 2008).

(36) AAPS Annual Meeting 2008, IPAC-RS 2008, ENAR 2008, Midwest Biopharmaceutical Statistics Workshop 2008, Non-Clinical Statistics Conference 2008 and AAPS Stability Workshop 2007.


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