Establishing a lab in biopharmaceutical fields such as cell and gene therapies can be challenging, with the need to meet strict Good Manufacturing Practice (GMP) regulations set by the FDA. Mary Kay Bates, a senior global cell culture scientist at Thermo Fisher Scientific, recently shared insights on best practices for implementing GMP regulations in the lab with Technology Networks. She highlighted common challenges labs face, such as transitioning equipment to meet GMP standards, ensuring equipment performance, and managing extensive documentation requirements.
To overcome these challenges, Bates suggests involving equipment manufacturers early, asking the right questions, and emphasizing good documentation. She also emphasizes the importance of internal collaboration among different departments and maintaining strong external partnerships with equipment manufacturers to ensure success in meeting GMP requirements from the start.
Additionally, Bates addresses the importance of promoting a culture of compliance and responsibility among lab personnel, starting with leadership setting the tone and providing regular training and clear communication.
Looking ahead, Bates mentions the challenges and opportunities labs face in adapting to evolving technologies while maintaining GMP compliance. Automation and digital monitoring systems can improve efficiency and compliance, but labs must ensure compatibility with existing IT infrastructure. By adopting new technologies thoughtfully, labs can improve compliance and operational performance, positioning themselves for success in the future.
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