Good Manufacturing practices is a quality system which ensure that the products are consistently produced and controlled as per the quality standards. GMP regulation provides guidance for manufacturing, testing and quality assurance to ensure that the manufactured product is safe for human consumption or use.
Implantation of GMP assures that the identity, strength, quality and purity of the products as the consumer cannot detect the safety of the product.
FDA inspects drug manufacturing facilities around the world which includes API manufacturers to check whether these companies implemented drug GMP regulations as per 21 CFR part 211. FDA will consider these drugs as adulterated if the company is not complying with GMP regulations.
Medical Device manufacturers must follow and implement quality system to ensure that their products consistently meet all medical device GMP regulations as per 21 CFR part 820. This quality system regulation is applicable to all finished device manufacturers who are planning to do commercial distribution in US. As per 21 CFR 820.3(i) a finished device is any type of device or attachment to any device that is fit for use or capable of working, whether or not it is packaged, labeled, or sterilized.
FDA has classified certain type of medical devices are exempt for GMP regulations, however it does not exempt the manufacturers of finished devices from GMP requirements.
FDA’s GMP regulation as per 21 CFR 820 is aligned with ISO 13485: 2016 to a greater extent than ISO 9001:2015 which is an internationally recognized quality system.
FDA inspects medical device manufacturing facilities to check whether their establishment is in compliance with 21 CFR 820 regulations. If the company is not in compliance with GMP regulations at the time of inspection, FDA will issue an Establishment inspection Report in observations listed on FDA form 483. It is the company’s responsibility to respond FDA 483 warning letter within 15 days and the response has to include the corrective measures taken by the company and preventive solutions taken to stop the recurrence.
Liberty Management Group, a leading FDA consulting group in the United States, provides assistance with 21 CFR 820 GMP regulations, ISO 13485 : 2016 and FDA 483 warning letters.
Sudha S
Regulatory Consultant
Mail : office@libertymanagement.us