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12 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING EBOOK 2021 P h a r mTe c h . c o m Manufacturing topic. It is important that both the industry and regu- lators consider this information if they are to make informed decisions to protect patients, as they relate to sterile filtration and the control of contamination in aseptic processing. Acknowledgment I would like to thank Hal Baseman, COO of Val- source, for his invaluable contributions and sup- port to this paper, the SFQRM consortium, and his scientific impact in the industry. References 1. PDA, Technical Report 26, Liquid Sterilizing Filtration, Parenteral Drug Association, Bethesda, MD, 2008. 2. FDA, Guideline on Sterile Drug Products Produced by Aseptic Processing (Division of Manufacturing and Product Quality, Office of Compliance, Center for Drugs and Biologics, Rock- ville, MD, 2004). 3. ISO, "ISO 13408-2:2003(E), Aseptic Processing of Health Care Products – Part 2: Filtration," ISO copyright office, Geneva, 2003. 4. Japanese Ministry of Health, Labour and Welfare (MHLW), "Ster- ile Drug Products Produced by Aseptic Processing," Tokyo, 2005. 5. Pharmaceutica l Inspection Convention (PIC/S), "Recom- mendation on the Validation of Aseptic Processes," Geneva, PI 007-2, 2004. 6. EU, EudraLex Volume 4, EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Annex 1, Manufacture of Sterile Medicinal Products (Brussels, 2008). 7. M.W. Jornitz and T.H. Meltzer, American Pharmaceutical Re- view, 14(5) (2011). 8. K. Bartel, et al., PDA Position Paper, PDA Journal of Pharmaceuti- cal Science and Technology, 66 (5), September–October 2012. 9. L. Hemisha, "Sterile Filtration: Clarification Proposal, Annex 1 Paragraph 113: Focus on Pre-Use Post-Sterilization Integrity Test- ing (PUPSIT)," PDA Meeting, Dublin, July 10th, 2011. 10. EMA, "EU GMP Guide Annexes–Supplementary Requirements – Annex 1 Manufacture of Sterile Medicinal Products" (June 2007). 11. ASTM, ASTM Standard F838-15, Standard Test Method for De- termining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration, American Society for Testing and Materials, West Conshohocken, PA, 1983, Revised 1988, 2005, 2015. 12. S.Ferrante, et al., PDA Journal of Pharmaceutical Science and Tech- nology 74 (5) 509-523, September 2020. 13. B. Thome, et. al., PDA Journal of Pharmaceutical Science and Tech- nology 74 (5) 524-56, September 2020. 14. PDA, "Points To Consider For Risks Associated With Steril- izing Grade Filters And Sterilizing Filtration," Parenteral Drug Association 2020. 15. PDA,"Points To Consider For Implementation Of Pre-Use Post- Sterilization Integrity Testing (PUPSIT)," Parenteral Drug As- sociation, 2020. PT ♦ ♦ CALL FOR PAPERS ♦ ♦ CALL FOR PAPERS ♦ ♦ CALL FOR PAPERS ♦ ♦ CALL FOR PAPERS ♦ ♦ ♦ ♦ CALL FOR PAPERS ♦ ♦ CALL FOR PAPERS ♦ ♦ CALL FOR PAPERS ♦ ♦ CALL FOR PAPERS ♦ ♦ Pharmaceutical Technology and Pharmaceutical Technology Europe cover all aspec t s of pharmaceutic al drug development and manufac turing , including formulation development, proces s d evel o p m e n t a n d m a nu f a c t uring of a c t i ve p h ar m a c eu t ic al ingredients (both small molecule and large molecules) and finished drug-products (solid dosage, semisolid, liquids, parenteral drugs and topical drugs), drug-deliver y technologies, analy tical methods development, analytical testing, quality assurance/quality control, validation and advances in pharmaceutical equipment, machinery, instrumentation, facility design and plant operations. We are currently seeking novel research articles for our peer-reviewed journal as well as manuscripts for our special issues. For peer-reviewed papers, members of the Editorial Advisory Board of Pharmaceutical Technology and Pharmaceutical Technology Europe and other industry experts review manuscripts on technical and regulatory topics. The review process is double-blind. Manuscripts are reviewed on a rolling basis. Our single-themed issues, which include literature reviews and tutorials, address excipients and ingredients, analytical testing, outsourcing, solid dosage and more. Please visit our website, www.PharmTech.com/view/pharmaceutical-technology-sub- mission-guidelines-and-editorial-calendars, to view our full Author Guidelines. Manuscripts may be sent to Editorial Director Rita Peters at RPeters@mjhlifesciences.com. We look forward to hearing from you. BILLIONPHOTOS.COM - STOCK.ADOBE.COM