Quality Compliance
Quality Compliance refers to adherence to regulatory standards, guidelines, and laws designed to ensure product safety, identity, strength, purity, and quality (SISPQ), particularly in the pharmaceutical, biotechnology, and medical device sectors. The FDA enforces quality compliance through regulations such as 21 CFR Part 820 for medical devices and 21 CFR Part 211 for pharmaceuticals.
Companies are required to establish and maintain robust Quality Management Systems (QMS) that include components like:
- Document control
- Change control
- CAPA (Corrective and Preventive Action)
- Audits and inspections
- Personnel training
Failure to meet quality compliance requirements can result in FDA warning letters, product recalls, fines, or other enforcement actions, which can get very expensive and impact a company’s financial position and reputation. For more details on the “cost of quality”, check out our two 2024 webinar recordings below:
Webinar Recording: Proactive vs. Reactive Quality: Building a Business Case for Quality Investments