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).
|
