Pharmaceutical Technology - March 2022

Pharmaceutical Technology March 2022

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34 Pharmaceutical Technology QUALITY AND REGULATORY SOURCEBOOK EBOOK MARCH 2022 P h a r mTe c h . c o m Regulations: Data Integrity T hroughout a single project, contract development and manufacturing organizations (CDMOs) generate an abun- dance of essential data that require an array of comput- erized systems to manage. These systems provide many benefits, including reducing human error, making processes more efficient, and enhancing security. More importantly, these systems can be used to help implement technical controls for data integrity (DI). The importance of ensuring DI, particularly when data are used in decision-making for the regulated good practice (GxP) processes, is highlighted by the consistent updating of regulations first man- dated by FDA in the early 1960s. Since that time, FDA and other regulatory agencies have continued to publish guidance emphasiz- ing the need to maintain DI controls. Before any new technology implementation, CDMOs need to fully understand the system as well as establish its intended use and perform risk mitigation to ensure robust DI controls. However, understanding and implementing the requirements of regulations surrounding computerized systems continues to be a challenge to many CDMOs today. Technology is not the predominant challenge to achieving regulatory compliance, but the lack of critical think- ing skills when designing a quality system. Importance of safeguarding DI Over the years, technological advancements have both accelerated the digitalization process while highlighting the many complexities involved in ensuring DI. How a Lack of Critical Thinking is Hindering Regulatory Compliance Calvin Kim Why critical thinking must be applied before technology to ensure regulatory compliance. Calvin Kim is the senior director, head of IT quality systems and validation, for Samsung Biologics. ANDRII ZASTROZHNOV - STOCK.ADOBE.COM

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