Issue link: https://www.e-digitaleditions.com/i/1462155
Pharmaceutical Technology QUALITY AND REGULATORY SOURCEBOOK EBOOK MARCH 2022 39 their quality management systems for better transpar- ency and oversight. Key lessons Robust governance programs to ensure DI throughout the lifetime of the data generated by CDMOs are criti- cal to decision making. Regulatory bodies have clearly outlined the requirements needed to safeguard DI, sup- ported by the guidelines that continue to discuss the ALCOA+ principles. However, it is clear from inspection reports that many manufacturers are still not demonstrating compliance. A common cause is the implementa- tion of digitalized solutions where there is no clear understanding or establishment of intended use and proactive approach to risk mitigations for the better quality design in the first place. It is, therefore, essential to identify a CDMO part- ner that is aware of the DI regulatory requirements and has built proactive, robust processes with a data-centric mindset in the implementation of the digitalized solutions. References 1. Redica Systems, "Data Integrity: The Whole Story," redica.com, April 9, 2015. 2. Redica Systems, "Data Integrity Trends in 483s and Warning Letters: Part 1," redica.com, May 16, 2019. PT reduced where possible. Fabric selection is key in reducing this risk. Future trends and practices PharmTech: Are there any plans for industry or regu- latory to consider the test protocol for future good practice guidelines? Dixon-Heathman (Cleanroom Management Associates): Stan- dards today research types of testing models to allow for continuous improvement. I am hopeful that the stan- dards organizations will review this type of testing and begin to add this test to standards. This testing could be performed by gowning designers to determine bet- ter fitting garment systems that reduce the risk of the billowing effect. Billowing risk could become a test that is required for gowning selection. Lifecycle testing must become a requirement to reduce the risk of contamination from personnel. The ISO standards committee is considering this testing as a requirement. PharmTech: 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 re- ducing 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 process 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 Monitor- ing," in Microbial Risk and Investigations, K.Z. McCullough and J. Moldenhauer, eds., pp. 413–441 (Parenteral Drug Asso- ciation, Bethesda, Md., April 2015). PT Quality: Cleanrooms — Contin. from page 26