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
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: Pharmaceutical Technology,
Click here