247
Views
5
CrossRef citations to date
0
Altmetric
Original Articles

Quality Considerations in the Establishment of Specifications for Pharmaceuticals

&
Pages 125-135 | Received 01 Apr 2010, Published online: 10 Aug 2012

References

  • ASQC Chemical and Process Industries Division . 1996 . “ Chemical Interest Committee ” . In Specifications for the Chemical and Process Industries: A Manual for Development and Use , Milwaukee, WI : ASQC Quality Press .
  • Chambers , D. S. and Wheeler , D. J. 1992 . Understanding Statistical Process Control , Knowville , TN : SPC Press .
  • Down , M. 2005 . Statistical Process Control (SPC) Reference Manual (2nd ed.) , Southfield, MI : AIAG . Available online through: http://www.aiag.org
  • Griffiths , K. and Murphy , J. January 2006 . “ Zero-Tolerance Criteria Do Not Assure Product Quality ” . In Pharmaceutical Technology 52 – 61 .
  • International Conference on Harmonization . 1999 . “Specifications: Test Procedures And Acceptance Criteria For New Drug Substances And New Drug Products: Chemical Substances, Q6A” (step 4 version) available online at http://www.ich.org/LOB/media/MEDIA430.pdf
  • IPAC-RS . 2002 . “A Parametric Tolerance Interval Test for Improved Control of Delivered Dose Uniformity of Orally Inhaled and Nasal Drug Products,” available online at http://www.ipacrs.com/PDFs/IPACRS_DDU_Proposal.PDF
  • Juran , J.M. 1998 . “How to Think about Quality” . In Juran’s Quality Handbook , 5th ed. , Edited by: Juran , J.M. and Godfrey , A.B. New York : McGraw-Hill . 2.1–2.18
  • Kurtulik , P. , Parente , E. , Tougas , T. , Tsang , P. , Warner , E. , Winter , W. and Wyvratt , J. M. April 2007 . “ Acceptable Analytical Practices for Justification of Specifications ” . In Pharmaceutical Technology 156 – 168 .
  • Novick , S. , Christopher , D. , Dey , M. , Lyapustina , S. , Golden , M. , Leiner , S. , Wyka , B. , Delzeit , H-J , Novak , C. and Larner , G. 2009 . “A Two One-Sided Parametric Tolerance Interval Test for Control of Delivered Dose Uniformity. Part 1—Characterization of FDA Proposed Test” . AAPS PharmSciTech , 10 ( 3 ) : 820 – 828 .
  • PhRMA Statistics and Stability Expert Teams . April 2003 . “ Identification of Out-Of-Trend Stability Results ” . In Pharmaceutical Technology 38 – 52 .
  • PhRMA Statistics and Stability Expert Teams . October 2005 . “ Identification of Out-Of-Trend Stability Results, Part II ” . In Pharmaceutical Technology 62 – 68 .
  • Schilling , E.G. 1998 . “Acceptance Testing” . In Juran’s Quality Handbook , 5th ed. , Edited by: Juran , J.M. and Godfrey , A.B. New York : McGraw-Hill . 46.1–46.87
  • U.S. Department of Health and Human Services, Food and Drug Administration . 2004 . “Challenge and Opportunity on the Path to New Medical Products” available online at http://www.fda.gov/, search for ucm113411.pdf
  • U.S. Department of Health and Human Services, Food and Drug Administration . 2006a . “Guidance for Industry, Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production” . available online at http://www.fda.gov/, search for ucm070287.pdf
  • U.S. Department of Health and Human Services, Food and Drug Administration . 2006b . “Guidance for Industry, Quality Systems Approach to Pharmaceutical CGMP Regulations,” available online at http://www.fda.gov/, search for ucm070337.pdf.
  • U.S. Department of Health and Human Services, Food and Drug Administration . 2007 . “Pharmaceutical Quality for the 21st Century A Risk-Based Approach Progress Report” available online at http://www.fda.gov/, search for ucm128080.htm
  • United States Pharmacopeia . 2006a . “Uniformity of Dosage Units” . USP 32, General Chapter 905

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.