Ensuring Regulatory Compliance: The Role of Validation in Pharmaceutical and Biotech Industries
In this Technology Networks article, Timothy Bolus, MPM, MBA, senior compliance product and program manager at Molecular Devices, discusses validation in the pharmaceutical and biotechnology sector with a focus on Title 21’s Good Manufacturing Practice (GMP).
The mandated practice is integral to the entire drug development process, proving that products and data are not adulterated and can be used in trials or sold commercially. Pharmaceutical and biotech companies must prove they comply with regulations to ensure their products are safe for human consumption.