Interventions Risk Evaluation and Management in Aseptic Manufacturing

References

1. 1.↵
   1. Sandle T.

   1. Tidswell E. C.

   1. Baseman H.,
   2. Hanff C. M.,
   3. Long M.

   Evaluation and Improvement of Aseptic Processes: Risk and Aseptic Process Improvement. In Aseptic and Sterile Processing: Control, Compliance, and Future Trends; Sandle T.; Tidswell E. C., Eds.; DHI Publishing LLC, 2017.
2. 2.↵
   1. Baseman H.,
   2. Hardiman M.,
   3. Henkels W.,
   4. Long M. A.

   Line of Sight Approach for Assessing Aseptic Processing Risk: Part III. PDA Letter, 2016.
3. 3.↵
   1. Ljungqvist B.,
   2. Reinmueller B.

   Microbial Risk Assessment in Pharmaceutical Clean Rooms; PDA: Bethesda, MD, 2001.
4. 4.↵
   1. Akers J.,
   2. Agalloco J. P.

   A Revised Aseptic Risk Assessment and Mitigation Methodology. Pharm. Technol. 2017, 41 (11), 32–39.

   OpenUrl
5. 5.↵
   1. Katayama H.,
   2. Toda A.,
   3. Tokunaga Y.,
   4. Katoh S.

   Proposal for a New Categorization of Aseptic Processing Facilities Based on Risk Assessment Scores. PDA J. Pharm. Sci. Technol. 2008, 62 (4), 235–243.

   OpenUrlAbstract/FREE Full Text
6. 6.↵
   1. Akers J. E.,
   2. Agalloco J. P.

   The Simplified Akers–Agalloco Method for Aseptic Processing Risk Analysis. Pharm. Technol. 2006, 30 (7).
7. 7.↵
   1. Whyte W.,
   2. Eaton T.

   Microbial Risk Assessment in Pharmaceutical Cleanrooms. Eur. J. Parenter. Pharm. Sci. 2004, 9 (1), 16–23.

   OpenUrl
8. 8.↵
   1. Hussong D.,
   2. Madsen R. E.

   Analysis of Environmental Microbiology Data from Cleanroom Samples. Pharm. Technol. 2004, 2004 Suppl. (3).
9. 9.↵
   Parenteral Drug Association Inc. Points to Consider for Aseptic Processing of Sterile Pharmaceutical Products in Isolators; Bethesda, MD, 2020.
10. 10.↵
    PDA Points to Consider for Aseptic Processing: Part 2, PDA, Bethesda, MD, 2011.
11. 11.↵
    The Rules Governing Medicinal Products in the European Union, Volume 4: Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex1: Manufacture of Sterile Medicinal Products, European Commission: Brussels, 2022.
12. 12.↵
    PDA Technical Report No. 22, Process Simulations for Aseptically Filled Products, Parenteral Drug Association, Bethesda, MD, 2011.
13. 13.↵
    Concept Paper on the Revision of Annex 1 of the Guidelines on Good Manufacturing Practice—Manufacture of Sterile Medicinal Products., European Medicines Agency and Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S), EMA: London, 2015.
14. 14.↵
    Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice, U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Office of Regulatory Affairs (ORA), September 2004.