Article | June 12, 2023

How To Balance cGMP And BSL-3 Regulatory Requirements

Source: Germfree

By Carol Houts , VP Quality-Regulatory, Germfree

Getty-484225106- Balancing Speed-to-Market With A Risk-based Approach To Compliance

It can be a complex challenge for biopharmaceutical companies to manage regulations for cGMP cleanroom and biosafety requirements. The conflict biopharmaceutical companies face when required to meet both cGMP cleanroom and biosafety requirements, can lead to problems that compromise product quality and safety.

Germfree provides a comprehensive understanding of the conflict between cGMP FDA 21 CFR Part 210 and 211 cleanroom and BMBL requirements. While some companies rely on separate protocols, Germfree believes a modular design could cut through the cGMP/BMBL conflict. Find the right solutions to comply and maintain product quality and safety for your company.

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