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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:
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.
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.
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 (QMSR) 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 (QMSR).
Sanner’s sites are FDA registered, ISO 13485 certified, and abide by current Good Manufacturing Practices. We operate multiple global sites with equivalent Quality Management Systems which are compliant with the requirements of ISO 13485 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 Sanner, including medical devices, drug delivery systems, and combination products.
If you are looking for a cGMP contract manufacturing partner, look no further than Sanner. 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 us today to learn more about our medical device manufacturing capabilities.