An Overview
In the United States, the Food and Drug Administration (FDA) creates regulations that govern the sale of food, drugs, biologics, and medical devices. The FDA mandates manufacturers in these industries to establish and maintain quality systems to ensure that their products meet their customers’ usability and safety requirements. Good Manufacturing practices, or GMPs, are the foundation of quality systems for FDA-regulated products.
A Guide to GMP Compliance for Medical Devices
- Design Control
- Document Control
- Production and Process Control
GMP Certificate for Medical Devices
A third-party organization will provide a GMP Certificate following an inspection of the plant in accordance with a protocol. Government organizations and certification bodies can issue it. GMP Certification supports your organization in ensuring regulatory compliance while showcasing your knowledge and commitment to producing safe, high-quality healthcare products for the public.
GMP Certificate Standards and Guidance
GMP Certificate is a component of a company’s quality system that covers the production and testing of active pharmaceutical components, diagnostics, foods, cosmetics, pharmaceutical goods, and medical devices until they reach the point of use.
GMP Certificate standards and recommendations specify the requirements for proper manufacturing process and facility design, monitoring, and control.