The Importance of Current Good Manufacturing Practices (cGMPs) in Medical Device Manufacturing

What are cGMPs?

Current Good Manufacturing Practices (cGMPs) refer to the regulations enforced by the US FDA that direct the design, monitoring, maintenance, and control of manufacturing processes and facilities.  The FDA enforces these regulations for medical devices, pharmaceutical products, food and beverages, and other products that fall under the FDA’s regulatory authority. Following cGMP regulations ensures the identity, quality, strength, and purity of commercial products by requiring that manufacturers adequately control manufacturing operations. Some of these controls include:

• Establishing a strong Quality Management System (QMS)
• Establishing and following robust set of standard operating procedures (SOPs)
• Appropriately documenting, storing, and controlling records of all development, manufacturing, and testing activities
• Ensuring employees are properly qualified and trained
• Using raw materials that meet appropriate quality standards
• Maintaining reliable testing methods
• Keeping manufacturing equipment and facilities clean and well-maintained
• Detecting and investigating product quality deviations

This formal system of controls helps to prevent contamination, mix-ups, deviations, failures, and errors, helping to ensure that products meet the necessary quality standards. CGMP regulations also require that manufacturers use modern technologies and innovative approaches to achieve higher quality through continuous improvement.

Why do cGMPs Matter?

Unless the flaw is obvious, consumers can not usually detect whether or not a drug product or medical device is safe and effective. If a product has passed regulatory clearance and made it on the market, consumers generally assume it is safe for use. CGMP standards set by the FDA exist to ensure that these products meet the government’s standards for safety and effectiveness. The regulatory oversight that comes from employing current Good Manufacturing Practices helps to prevent products that are defective, contaminated, unsafe, or ineffective from getting into the hands of consumers. Testing alone is not adequate enough to ensure quality and safety, therefore it is important that drugs and medical devices are manufactured under the conditions and practices set forth by cGMP regulations. This will ensure that quality is built into the design and manufacturing process of a given product.

Do Medical Device Manufacturers Have to Follow cGMP Regulations?

Medical device manufacturers are required to follow all applicable FDA guidelines, including compliance with current Good Manufacturing Practices. The Code of Federal Regulations Title 21 Part 820 outlines the regulations that medical device companies are required to follow. FDA cGMP guidelines call for manufacturers of medical devices to establish and maintain policies that ensure device design requirements and other decisions are well-documented and adequately justified. These guidelines are broad, allowing them to be applied to a variety of medical devices.  It is up to the manufacturer to determine how to best apply the guidelines in order to achieve compliance.  The FDA conducts regular inspections of medical device manufacturing facilities to make sure they remain in compliance with cGMPs and 21 CFR Part 820.

Current Good Manufacturing Practices at Gilero

Gilero is FDA registered, ISO 13485 certified, and abides by current Good Manufacturing Practices. We operate under a robust Quality Management System (QMS) to help facilitate our compliance with cGMPs, ensuring we produce products of the utmost quality that meet all safety and efficacy standards. CGMP regulations apply to all of the products manufactured by Gilero, including medical devices, drug delivery systems, and combination products.

If you are looking for a cGMP contract manufacturing partner, look no further than Gilero. We provide a full suite of manufacturing services, including design transfer, injection molding, complex assembly, packaging, and kitting. With a proven capacity to innovate and scale, our domestic and international manufacturing facilities allow us to service medtech clients across the globe. Contact Gilero today to learn more about our medical device manufacturing capabilities.