Understanding 21 CFR Part 4

21 CFR Part 4 outlines the legal requirements for Good Manufacturing Practice (cGMP) for combination products in the United States. The regulation ensures that the constituent parts of combination products, whether they are pharmaceuticals, biologics, or medical devices, maintain their individual regulatory statuses even when combined. This means that the cGMP requirements applicable to each component remain in effect throughout the lifecycle of the combination product.

Proactive Compliance Support

Since the enactment of 21 CFR Part 4, confinis has been at the forefront, helping numerous clients navigate these complex regulations. Our expertise allows us to proactively assist clients in achieving and maintaining compliance with these rigorous standards.

Gap Analysis and Design Control Support

Our approach includes conducting a detailed “gap analysis” to identify and address discrepancies between your current practices and the requirements set forth in 21 CFR Part 4. We work collaboratively with you to develop a concrete plan to close these gaps. Based on our extensive experience, we understand common challenges and effective solutions, particularly in areas such as design control, where many clients seek additional support.

Why is Compliance with 21 CFR Part 4 Important?

Compliance with 21 CFR Part 4 is crucial as it ensures that each component of a combination product is manufactured according to the highest quality standards, thereby safeguarding efficacy and patient safety. Maintaining the regulatory integrity of individual components within a combination product not only meets legal requirements but also builds trust with healthcare providers and patients.

By choosing confinis for your 21 CFR Part 4 compliance needs, you gain access to deep regulatory expertise and practical solutions that help streamline your manufacturing processes and enhance product quality.