Gmp Guidelines For Medical Devices

Under section 520 f of the act fda.

Gmp guidelines for medical devices.

This regulation governs the methods controls and facilities used used in the design manufacture packaging labeling storage installation servicing and maintenance of all finished medical devices for human use. New who guideline for medical devices and ivds. The fda is revising the current good manufacturing practice cgmp requirements for medical devices and incorporating them into a quality system regulation. Gmp for medical devices compliance with en iso 13485 and gmp the increasing co operation of medical device manufacturers with pharmaceutical companies makes it necessary to approximate quality management system according to en iso 13485 to gmp requirements.

Since 1996 the requirements for the development the manufacture and the distribution of medical devices in the usa have been laid down in the revised cgmp regulations for medical devices 21 cfr 820 qsr. 21 cfr 820 good manufacturing practices cgmp for the medical device industry deals with having a solid quality management system qms in place that is traceable and auditable. The first world health organization who draft text on good manufacturing practices gmp was prepared at the request of twentieth world health assembly in 1967 by a group of consultants. Eudralex volume 4 good manufacturing practice gmp guidelines volume 4 of the rules governing medicinal products in the european union contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in commission directives 91 356 eec as amended by directive 2003 94 ec and 91 412 eec respectively.

Many countries now require that pharmaceutical and medical device companies must follow gmp regulations and have created their own gmp guidelines. This determines the applicable regulatory framework. Common borderlines are between medicinal products medical devices cosmetics biocidal products herbal medicines and food supplements. Gmp certifications guidelines under who gmp scheme.

After issuing the second draft of a global medical devices regulation the who has published a finalised 76 page regulatory framework for medical devices including in vitro diagnostic medical devices ivds divided into 5 chapters. Failure of firms to comply with gmp regulations can result in product recall or seizure fines and prison. In the usa medical devices are regulated by the fda s center for devices and radiological health cdrh. Cgmp requirements for devices in part 820 21 cfr part 820 were first authorized by section 520 f of the federal food drug and cosmetic act the act.

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