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www.biopharminternational.com Quality and Regulatory Sourcebook eBook March 2022 BioPharm International 29 Quality and Regulatory Sourcebook Regulations: Supply Chain costly, and resource-intensive to successfully monitor and man- age convoluted and constantly mutating logistical formations. Industry consultation Clearly, it is absolutely crucial that the component parts of the MMCS pro- gram accurately ref lect the needs and priorities of the potential user base and other stakeholders. For this reason, an official MMCS Consultation Cluster has been estab- lished comprising volunteer experts from a broad spectrum of the indus- try's stakeholder groups to advise on the program and ensure its neutral, non-partisan status. Figure 4 shows the current per- centage breakdown of the MMCS Consultation Cluster by category. Input is being solicited from both individuals and organizations from right across the industry including responsible persons, established best-practice agencies, quality bodies, and regulatory authorities. The goal is to engage with the industry to improve, consolidate, and standardize the pharma-logistics process without unnec- essary duplication, toe-treading, or rein- venting of wheels. CONCLUSION The distribution of life-saving and life-enhancing medicines has recently been center stage in the public domain as a result of the continuing COVID- 19 crisis. However, the pandemic is not only a tragedy; it is an opportunity and a turning point. With so much at stake and no end in sight, it is time for the industry to come together to find ways of improving and harmonizing how the industry complies with the rules sur- rounding the safe and efficient distribu- tion of vital medicines. REFERENCES 1. EC, Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use. 2. EC, 94/C 63/03 Guidelines on Good Distribution Practice of Medicinal Products for Human Use. 3. EC, 2013/C 343/01 Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use. 4. EC, 2015/C 95/01 Guidelines of 19 March 2015 on principles of Good Distribution Practice of Active Substances for Medicinal Products for Human Use. 5. BSI/Poseidon, "BSI/Poseidon MMCS program - GDP Consultation Cluster Survey Report, February 2022: "A review of pharma good distribution practice (GDP) based on industry-wide surveys conducted in November 2021." 6. BSI, "BSI and Poseidon to Collaborate on Global, Multi- modal Good Distribution Practice (GDP) Compliance Program for Medicines and Vaccines," Press Release, June 10, 2021 7. E. Krasteva and P. Brown, "Qualifications of Suppliers and Customers Online: Reliable or Fake News?," MHRA, Dec. 21, 2020. BP Figure 4. Breakdown of Multi-Mode Compliance & Standards (MMCS) program Consultation Cluster by category. Lifecycle testing must become a requirement to reduce the risk of con- tamination from personnel. The ISO standards committee is considering this testing as a requirement. BioPharm: Can you comment on any other trends in or concerns about gowning that you see in industry? Dixon-Heathman (Cleanroom Management Associates): Some firms recently have looked at better fitting hoods, goggles, and masks. Other firms are reducing the number of personnel in gownrooms to reduce the risk during gowning. Some gowning sequences have been changed to ensure that face masks are donned earlier in the gowning pro- cess to reduce the risk during gowning. Helmke drum testing is being requested by users for cleanliness of garments. But, the largest change in industry is the review of the age of the garment. The number of cycles is being challenged to ensure that the cleanroom garments are not a risk to the product and process. REFERENCES 1. A. Dixon-Heathman, "A Real- World Approach to Evaluating Cleanroom Garments," Pharmaceutical Technology Regulatory Sourcebook eBook (March 2021). 2. A. Dixon-Heathman, "Investigations for Personnel Monitoring," in Microbial Risk and Investigations, K.Z. McCullough and J. Moldenhauer, eds., pp. 413– 441 (Parenteral Drug Association, Bethesda, Md., April 2015). BP Quality: Cleanrooms — Contin. from page 11