Ensuring quality control in advanced therapeutics: the importance of cGMP-compatible equipment selection in QA/QC laboratories

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Equipment selection doesn’t end at the cleanroom door. Selecting appropriate equipment for advanced cell and gene therapeutics based on cGMP compatibility extends beyond the traditional production environment and into supporting processes like R&D and quality control. Equipment in these labs needs to meet the highest standards for performance and qualification, whilst being flexible enough to meet the demands of protocol modifications.

In advanced therapeutics, QA/QC involves a comprehensive set of processes and procedures to verify that products meet defined quality standards and regulatory requirements. It encompasses various aspects including raw material testing, in-process testing, and final product testing, to ensure that all stages of manufacturing and production adhere to quality specifications. During this testing, basic accessory equipment like incubators, environmental chambers, orbital shakers, etc., play a crucial role in the QA/QC process by providing controlled and stable conditions for testing and monitoring various parameters. This monitoring can identify of potential issues, such as microbial contamination, product degradation, or packaging failures, ensuring that products meet the required quality standards before reaching the market.

By utilizing robust cGMP compatible equipment, organizations can replicate real-world conditions and evaluate product performance accurately. Keeping the cGMP compatibility of equipment in mind during selection protects the long-term integrity of the QA/QC laboratory throughout the development and production process.

• Identify the performance and reproducibility specifications that are key to ensuring a piece of equipment meets the cGMP selection criteria
• Understand the importance of equipment qualification options like IQ/OQ/PQ on cGMP compatibility
• Recognize the features of laboratory equipment that emphasize application flexibility to meet the long-term needs of an everchanging QA/QC program

Kindra Whitlatch

Product Applications Manager at Thermo Fisher Scientifc

Kindra Whitlatch is a Product Applications Manager at Thermo Fisher Scientific, with over 15 years of experience in laboratory equipment usage and selection. Kindra specializes in the use of equipment in the life science laboratory, including environmental chambers, microbiological incubators, and orbital shakers. Currently, she is responsible for training and supporting colleagues and customers in the appropriate use of laboratory equipment in a variety of lab spaces. She holds an MS in Molecular Biophysics and Structural Biology from the University of Pittsburg School of Medicine and a BS in Chemistry from West Virginia Wesleyan College.

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Kindra Whitlatch

Product Applications Manager at Thermo Fisher Scientifc

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