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

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
27%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
8%
All of the above.
41%
No government involvement in patient treatment or drug development.
11%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: Pharmaceutical Technology,
Click here