Joint Position Paper on Pharmaceutical Excipient Testing and Control Strategies - Pharmaceutical Technology

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Joint Position Paper on Pharmaceutical Excipient Testing and Control Strategies
This article presents collaborative positions among excipient manufacturers, drug product manufacturers, and members of the US Pharmacopeia on key issues pertaining to the control of pharmaceutical excipients stemming from a recent Pharmaceutical Quality Research Institute workshop.


Pharmaceutical Technology


8. FDA, Pharmaceutical CGMPs for the 21st Century—A Risk-Based Approach: Final Report, http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm#_Toc84065754.

9. R.C. Moreton, "Excipient Functionality," Pharm. Technol. 28 (5), 98–104 (2004).

10. M. Rios, "Debating Excipient Functionality," Pharma. Technol. 30 (9), 50–60 (2006).

11. PhEur, Proposed General Chapter 5.15: "Functionality-Related Characteristics of Excipients," Pharmeuropa 18.3 (July 2006).

12. R.C. Moreton, "Functionality and Performance of Excipients," Excipients Performance, supplement to Pharm. Technol., s4–s14 (Oct. 2006).

13. The IPEC-Americas Significant Change Guide for Bulk Pharmaceutical Excipients (first revision, IPEC-Americas, Jan. 2005).

14. "General Notices, Section Tests and Assays—Procedures," in USP 30–NF 25 (US Pharmacopeial Convention, Rockville, MD, 2007), p. 7.

15. Joint IPEC–PQG Good Manufacturing Practice Guide For Pharmaceutical Excipients (2006), http://www.ipecamericas.org/.

16. FDA, Guideline For Drug Master Files, http://www.fda.gov/cder/guidance/dmf.htm.

17. IPEC, IPEC Excipient Master File Guideline, http://www.ipecamericas.org/.

18. "Substances Generally Recognized As Safe," 21 CFR Parts 182, 184, and 186, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm.

19. FDA, Guidance for Industry—Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients, http://www.fda.gov/cder/guidance/5544fnl.htm.

20. "Laboratory Records," 21 CFR 211.194(a)(2), http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.194.

21. "Excipients and Addenda," Chapter 3 in USP Submission Guide, http://www.usp.org/USPNF/submitMonograph/subGuide.html.

22. FDA, Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC), http://www.fda.gov/cder/guidance/7386dft.htm (also see 71 FR 45059, Aug. 8, 2006).


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