Parametric Release of Moist Heat Sterilized Products: History and Current State

References

1. 1.↵
   U.S. Food and Drug Administration. Guidance for Industry: Submission of Documentation in Application for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes. Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 2010.
2. 2.↵
   U.S. Pharmacopeial Convention, General Chapter <1222> Terminally Sterilized Pharmaceutical Products-Parametric Release, Sterility Tests. In USP-NF, Issue 1, USP: Rockville, MD, 2022.
3. 3.↵
   European Commission, EudraLex—The Rules Governing Medicinal Products in the European Union, Volume 4: Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 17: Real Time Release Testing and Parametric Release. https://www.gmp-compliance.org/files/guidemgr/2018_annex17_en.pdf (accessed June 2, 2022).
4. 4.↵
   Parenteral Drug Association Inc. Technical Report No. 30 (Revised 2012): Parametric Release of Pharmaceutical and Medical Device Products Terminally Sterilized by Moist Heat; Bethesda, MD, 2012.
5. 5.↵
   Kilmer Conference Process Analytical Technology (PAT) and Current Moist Heat Sterilization Practice. https://parametricrelease.org/wp-content/uploads/2022/08/Kilmer-PAT-and-MH-Survey-Final-Results-149-052920.pdf (Accessed August 25, 2022).
6. 6.↵
   1. Gaughran E. R. L.,
   2. Kereluk K.,
   3. Wang Y-S

   1. Gaughran E. R. L.,
   2. Kereluk K.

   Preface. In Sterilization of Medical Products; Gaughran E. R. L., Kereluk K., Wang Y-S, Eds.; Johnson & Johnson: New Brunswick, NJ, 1977; pp XXV.
7. 7.↵
   International Organization for Standardization, ISO 11139:2018 Sterilization of Healthcare Products – Vocabulary –Terms Used in Sterilization and Related Equipment and Process Standards. ISO: Geneva, 2018.
8. 8.↵
   Parenteral Drug Association Inc. Technical Report No. 1 (Revised 2007), Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control; Bethesda, MD, 2007.
9. 9.↵
   General Council of Medical Education and Registration of the United Kingdom. Tests for Sterility. In British Pharmacopoeia. Constable & Co.: London, 1932; pp 632–633.
10. 10.↵
    U.S. Pharmacopeial Convention, General Chapter <71> Sterility Tests. In USP 41—NF 36, Supplement 2, USP: Rockville, MD, 2018.
11. 11.↵
    Council of Europe, Sterility, Chapter 2.6.1. In European Pharmacopoeia (Ph. Eur.), 10th Edition, Supplement 10.5. Council of Europe: Strasbourg, France, 2021.
12. 12.↵
    British Pharmacopoeia Commission. Test for Sterility. In British Pharmacopoeia; Lavoisier, 2021; Appendix XVI A.
13. 13.↵
    Ministry of Health Labour and Welfare of Japan, General Test, Process and Apparatus—JP 4.06: Sterility Test. In The Japanese Pharmacopoeia, 17 Edition (English Version), MHLW: Tokyo, 2016.
14. 14.↵
    U.S. Pharmacopeial Convention, General Chapter <1222> Terminally Sterilized Pharmaceutical Products—Parametric Release. In USP 33—NF 23, USP: Rockville, MD, 2010.
15. 15.↵
    1. Vartoukian S. R.,
    2. Palmer R. M.,
    3. Wade W. G.

    Strategies for Culture of ‘Unculturable’ Bacteria. FEMS Microbiol. Lett. 2010, 309 (1), 1–7.

    OpenUrlCrossRefPubMedWeb of Science
16. 16.↵
    1. Téllez S.,
    2. Casimiro R.,
    3. Vela A. I.,
    4. Fernández-Garayzábal J. F.,
    5. Ezquerra R.,
    6. Latre M. V.,
    7. Briones V.,
    8. Goyache J.,
    9. Bullido R.,
    10. Arboix M.,
    11. Domínguez L.

    Unexpected Inefficiency of the European Pharmacopoeia Sterility Test for Detecting Contamination in Clostridial Vaccines. Vaccine 2006, 24 (10), 1710–1715.

    OpenUrlPubMed
17. 17.↵
    1. Odlaug T. E.,
    2. Ocwieja D. A.,
    3. Purohit K. S.,
    4. Riley R. M.,
    5. Young W. E.

    Sterility Assurance for Terminally Sterilized Products without End-Product Sterility Testing. J. Parenter. Sci. Technol. 1984, 38 (4), 141–147.

    OpenUrlPubMed
18. 18.↵
    Committee for Comprehensive Review of DoD Laboratory Procedures, Processes, and Protocols Associated with Inactivating Bacillus anthracis Spores. Review Committee Report: Inadvertent Shipment of Live Bacillus anthracis spores by DoD. United States of America Department of Defense, 2015.
19. 19.↵
    U.S. Food and Drug Administration. 21 CFR Part 211—Current Good Manufacturing Practices for Finished Products. Subpart 167 Special Testing Requirements (a). https://www.govinfo.gov/content/pkg/CFR-2011-title21-vol4/pdf/CFR-2011-title21-vol4-part211.pdf (accessed June 2, 2022).
20. 20.↵
    U.S. Food and Drug Administration. Compliance Policy Guide (CPG) Sec. 460.800: Parametric Release—Terminally Heat Sterilized Drug Products, Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services. Government Publishing Office: Washington, D.C., 1987.
21. 21.↵
    1. Stevens-Riley M.

    Parametric Release: A Regulatory Perspective. Am. Pharm. Rev. 2015. https://www.americanpharmaceuticalreview.com/Featured-Articles/174390-Parametric-Release-A-Regulatory-Perspective/ (accessed June 2, 2022).
22. 22.↵
    European Medicines Agency. Guideline on Real Time Release Testing (Formerly Guideline on Parametric Release), 2012. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-real-time-release-testing-formerly-guideline-parametric-release-revision-1_en.pdf (accessed June 2, 2022).
23. 23.↵
    U.S. Food and Drug Administration. Compliance Policy Guide (CPG) Sec. 490.200 Parametric Release—Parenteral Drug Products Terminally Sterilized by Moist Heat, Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services. Government Publishing Office: Washington, D.C., 2012.
24. 24.↵
    Ministry of Health, Labour and Welfare of Japan. Guidance on the Manufacture of Sterile Pharmaceutical Products Produced by Terminal Sterilization. MHLW: Tokyo, 2012.
25. 25.↵
    European Medicines Agency. Note for Guidance on Parametric Release, 2001. https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-parametric-release_en.pdf (accessed June 2, 2022).
26. 26.↵
    European Commission, EudraLex—The Rules Governing Medicinal products in the European Union, Volume 4: Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 17: Real Time Release Testing and Parametric Release. European Commission: Brussels, 2018.
27. 27.↵
    Australian Government Department of Health Therapeutic Goods Administration. PE009, the PIC/S Guide to GMP for Medicinal Products. TGA, 2020.
28. 28.↵
    Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S), Recommendation on Guidance on Parametric Release. PIC/S: Geneva, 2007.
29. 29.↵
    Health Products and Food Branch Inspectorate, 2008. https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/hpfb-dgpsa/pdf/compli-conform/gui-0046-eng.pdf (accessed June 2, 2022).
30. 30.↵
    Health Sciences Authority, 2022. https://www.hsa.gov.sg/docs/default-source/hprg/therapeutic-products/guidance-documents/guidance-on-therapeutic-product-registration-in-singapore_jan2019.pdf (accessed June 2, 2022).
31. 31.↵
    Brazilian Health Surveillance Agency (ANVISA). Chapter 7.5 Procedures for Release. In Brazilian Pharmacopeia, 5th Edition; ANVISA, 2010.
32. 32.↵
    Ministry of Health ANVISA. Resolution of the Collegiate Board—RDC No 291, of June 24, 2019. https://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2019/rdc0291_24_06_2019.pdf (accessed June 2, 2022).
33. 33.↵
    Parenteral Drug Association Inc. Technical Report No. No. 54: Quality Risk Management for Aseptic Processes; Bethesda, MD, 2008.