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36 BioPharm International Quality and Regulatory Sourcebook eBook March 2022 www.biopharminternational.com REGULATORY CONSIDERATIONS BioPharm: What particular regula- tory requirements should companies be aware of when ensuring their products are secure within the supply chain? Lenox (LGM): The Drug Supply Chain Security Act was enacted in 2013 to further secure the drug supply. It cre- ates a tighter, closed prescription drug distribution system to prevent harmful drugs from entering the supply chain, detect harmful drugs if they do enter the supply chain, and enable rapid response when such drugs are found. The law requires drugs to be traced as they move through the supply chain, and compa- nies should only conduct business with licensed or registered trading partners. Kirk (Catalent): Over the past two years or so, supply chain challenges caused by the pandemic have led to many companies looking to consider alternative suppliers, products, and geo- graphical solutions to avoid disruption. However, it is important that these options never come with the risk of lower quality. It is always paramount to ensure that supplier compliance and integrity is assessed to relevant standards. Catalent uses several supplier monitoring tools, which range from supplier performance management, third-party risk monitor- ing, supplier audits and, finally, critical material risk assessments and tracking. Together, these create a multi-layered approach so that macro- and micro-level risks to supply can be identified and prevented or rectified. BP Quality and Regulatory Sourcebook Regulations: Supply Chain manufacturers used GA MP5, CSA principles are also applicable. Here are some examples of CSA principles that are found in GAMP5: • Av o i d d u p l i c a t i o n o f a c t i v i- t ies (e.g., by f u l ly integ rat ing engineering and computer system activities so that they are only per- formed once). • L everage suppl ier act iv it ies to t he ma x imu m possible e x tent, whi le sti l l ensuring f itness for intended use. • Scale all life cycle activities and associated documentation accord- ing to risk, complexity, and novelty. • Recognize that most computerized systems are now based on configu- rable packages, many of them net- worked (e.g., cloud-based software as a service). • Acknowledge that traditional lin- ear or waterfall development mod- els are not the most appropriate in all cases. • Science based risk management • Limited use of screen shots as test evidence. • Use of software development tools and automation. This is not an all-inclusive list, but it provides an idea about applying crit- ical thinking that focuses on deliver- ing a compliant application that is fit for its intended use. BEST PRACTICES BioPharm: Can you give an example of risk-based CSA best practices for the life sciences industry? FISCA: The application of CSA enables more time to be spent testing systems vs. generating documentation that serves little value. For example, the use of unscripted test cases and tools enables testing to focus on the detection of software defects. Manufacturers can dynamically test a system using experi- ence and knowledge while adjusting test design based on actual system behav- ior during test execution. Scripted test cases do not allow for the deviation from the prescribed test steps and therefore does not facilitate the use of the testers knowledge of the system and its associ- ated business process. Unscripted test case does not mean undocumented. The level of documen- tation retained is proportional to the risk of the feature, function, or operation being tested. For example, even a high- risk item could be tested in an unscripted fashion provided additional effort on planning to ensure coverage and trace- ability is performed. Another best practice is taking credit for activities performed throughout the software lifecycle. This can include lever- aging the vendor's software quality assur- ance processes. It could also include the leveraging of informal testing performed during factory acceptance testing. The activities prior to the start of validation are the basis for determining what additional assurance activities are needed vs. repeating activities for the sake of documentation for audi- tors. In both examples, the organiza- tion should establish a quality system framework that fulf ills the require- ments and creates records using least burdensome activities. The use of screenshots as the primary means of evidence capture should be avoided and reserved for use when it is value added (i.e., more eff icient or more robust). The use of computer system validation tools such as application lifecycle management, bug tracking, and automation should be embraced to reduce this effort. The people and organization performing the assurance activities should believe the efforts are meaningful and value added. THE FUTURE OF CSA BioPharm: What is the importance of CSA to pharmaceutical manufactur- ing? What role do you expect CSA to play in pharma manufacturing as more facilities move to digitalization? FISCA: We are already seeing many pharmaceutical manufacturers embrac- ing CSA and making it an integral part of their CSV process. CSA has already been very impactful in accelerating time to value when implementing software systems for many of these manufac- turers. CSA will enable companies to adopt new technologies more quickly, more efficiently, more reliably, and with higher quality. BP Quality: Validation — Contin. from page 9