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
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
26%
Attracting a skilled workforce
29%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
31%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: Pharmaceutical Technology,
Click here