The FDA cGMP standards exist to ensure that protected products sold to Americans meet the government's standards for safety and effectiveness.
The term, cGMP, refers to the Current Good Manufacturing Practice regulations developed and enforced by the United States FDA. These regulations are designed to enhance consumer confidence by providing for systems to assure proper design of products and adequate monitoring and control of manufacturing processes and facilities. The FDA has published cGMPs for products across a variety of industries, including dietary supplements, drugs and pharmaceutical products, and food processing.
In October 1996, the FDA published a final rule on medical device cGMP indicating that it would revise the current requirements for medical devices and incorporate the regulations for medical device quality systems that we know today as 21 CFR Part 820. This part of the Federal Code of Regulations deals with the requirements for medical device quality systems that ensure the safety and effectiveness of medical devices sold in the United States.
cGMP Regulations Offer a Framework for Compliance
There are thousands of medical devices on the market and each one is unique - it would be impossible for the FDA to release detailed guidelines for the good manufacturing of each individual device. Instead, the FDA cGMP provides broad guidelines that can be applied to a variety of different medical devices. It is up to manufacturers to determine how best to apply the guidelines to their unique product to achieve compliance.
Rather than providing medical device companies with prescriptive design and manufacturing requirements, the FDA cGMP requirements in Part 820 requires medical device manufacturers to establish and maintain policies which ensure that design requirements and other decisions are documented and adequately justified.
This flexibility promotes innovation by allowing manufacturers to decide how best to implement the necessary controls. Medical device companies can implement design features, processing methods, and testing procedures that are appropriate for their unique product and circumstances, leverage modern technology and pioneer new and innovative techniques and approaches.
How Does the FDA Evaluate cGMP Compliance?
Medical device manufacturers are responsible for establishing requirements, methods, and procedures that will result in the manufacturing of safe and effective medical devices that meet the quality system requirements. While manufacturers may delegate or outsource the work of compliance, they may not outsource the responsibility for manufacturing quality products.
The FDA conducts regular inspections of medical device manufacturers to ensure that they are building products in compliance with 21 CFR Part 820. The inspection process known as QSIT will investigate the quality systems of a medical device company and determine its compliance with the FDA's management responsibility controls, design control requirements, and production and process control requirements. Reports from the FDA show CAPAs to be one of the most common issues found during these inspections, so it’s imperative for device companies to establish and maintain an effective Corrective and Preventive Action (CAPA) plan to avoid potential citations.
Greenlight Guru Helps You Comply With FDA cGMP
Greenlight Guru's electronic quality management system (eQMS) makes it easier than ever for medical device companies to establish and maintain compliance with 21 CFR Part 820 and the good manufacturing practices required by the FDA. With our industry-specific platform, medical device companies can seamlessly document their product development activities, establish critical links between user needs, design features, and risk management concerns and quickly generate comprehensive reports that demonstrate FDA compliance of your design controls.
Corrective and Preventive Actions are the lifeblood of an effective quality management system. With Greenlight Guru, medical device companies can track their CAPA activities through an intuitive dashboard, manage quality events amongst teams and partners and save time during inspections with automated reports that demonstrate regulatory compliance.