USP <1211>: The Compendial Informational Chapter on Sterility Assurance - Pharmaceutical Technology

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USP <1211>: The Compendial Informational Chapter on Sterility Assurance
The author provides a history of the information chapter USP 91211: "Sterilization and Sterility Assurance of Compendial Articles," from the early 1900s to the current version.


Pharmaceutical Technology


Acknowledgment

The author would like to acknowledge and thank the contributions of Radhakrishna Timuralai and James Agalloco to the completion of this article.

Scott Sutton, PhD, is a consultant at Vectech Pharmaceutical Consultants, tel. 585.594.8273,

References

1. L. Anderson and G.J. Higby, The Spirit of Volunteerism: A Legacy of Commitment and Contribution. The United States Pharmacopeia 1820–1995 (US Pharmacopeial Convention, Rockville, MD, 1995).

2. USP IX, "Sterilization," pp. 616–617 (1916).

3. W.M. Heller, "USP and the Drug Regulation Reform Act," PDA J. Paren. Drug Assoc. 33 (2), 55–60 (1979).

4. B. Immel, "A Brief History of the GMPs," BioPharm 15 (8), 18–24 (2000).

5. "Drugs: Current Good Manufacturing Practice in Manufacture, Processing, Packing or Holding," Federal Register 28 Part 133, p. 6385 (June 20, 1963).

6. P. Shadle, "Overview of GMPs," Biopharm Intl. 18 (11), 8–14 (2004).

7. B. Matthews, "The Devonport Incident, the Clothier Report, and Related Matters: 30 Years On," PDA J. Pharm Sci. Technol. 56 (3), 137–149 (2002).

8. USP XIII, "Sterilization Processes," pp. 692–699 (1947).

9. S. Sutton, "Sterilization" in Pharmaceutical Quality Control Microbiology: A Guidebook to the Basics (DHI Publishers, 2007).

10. USP XVI, "Sterilization," pp. 839–841 (1960).

11. USP XVII, "Sterilization," pp. 810-814 (1965).

12. USP XVII, "Sterilization," pp. 830–835 (1970).

13. USP XIX "Sterilization," pp. 709–714 (1975).

14. USP XIX "Sterility Tests," pp. 592–595 (1975).

15. USP XX Chapter ‹1211›, "Sterilization," pp. 1037–1040 (1980)

16. USP XX Chapter ‹71›, "Sterility Tests," pp. 878–882 (1980).

17. "‹1211› Sterilization and Sterility Assurance of Compendial Articles," Pharm Forum 8 (3), 2073–2088 (1982).

18. "‹1211› Sterilization and Sterility Assurance of Compendial Articles," Pharm Forum. 9 (3), 2958–2971 (1983).

19. "‹1211› Sterilization and Sterility Assurance of Compendial Articles," Pharm Forum. 9 (5), 3513-3526.

20. USP XXI Chapter ‹1211›, "Sterilization and Sterility Assurance of Compendial Articles," pp. 1347–1352 (1985).

21, "‹1211› Sterilization and Sterility Assurance of Compendial Articles," Pharm Forum. 12 (2), 1221 (1986).

22. "‹71› Sterility Tests," Pharm Forum. 12 (4), 1604–1605 (1986).

23. USP XXII Chapter ‹1211›, "Sterilization and Sterility Assurance of Compendial Articles," pp. 1705–1710 (1990).

24. "‹1211› Sterilization and Sterility Assurance of Compendial Articles," Pharm Forum. 16 (4), 687–689 (1990).

25. USP 23 Chapter ‹1211›, "Sterilization and Sterility Assurance of Compendial Articles," pp. 1976–1981 (1995).

26. J.E. Akers and J. Agalloco, "Sterility and Sterility Assurance," PDA J Pharm Sci Tech. 51 (2), 72–77 (1997).

27. S.V.W. Sutton, J.E. Knapp, and R. Dabbah, "Activities of the USP Microbiology Subcommittee of Revision During the 1995–2000 Revision Cycle," PDA J Pharm Sci Technol. 55 (1), 33–48 (2001).

28. "‹1211› Sterilization and Sterility Assurance of Compendial Articles," Pharm Forum. 30 (5), 1729–1739 (2004).


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