GMP, as one of the types of quality management system for medical devices, one of the basic conditions for companies applying for certification is that the company must have established and operated the system for 3-6 months in order to provide the organization with the resources, capabilities, and track record to operate the GMP system. Therefore, it takes 3-6 months for an organization to establish and apply for GMP certification.
GMP certification is based on the U.S. government's 21CFR820.1, often referred to as QSR820 or GMP820, a quality system specification that incorporates the requirements of current GMPs, which are mentioned as controlling the design, production, labeling, storage, assembly, maintenance services, and equipment and control methods used in the design, production, labeling, storage, assembly, and maintenance of all finished devices intended for use in the human body. equipment and control methods used in these processes. The requirements of the Code are designed to ensure the safety and efficacy of finished devices while complying with the Food, Drug and Cosmetic Code (the Code). The Code establishes the basic requirements applicable to manufacturers of finished devices. If a lifetime product is involved in only some of the areas specified in the Code, but not others, the manufacturer need only comply with the requirements of the Code for the area in which it is involved. In the case of Class I devices, the design applies only to those devices listed in section 820
.30(a)(2).
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This specification does not apply to manufacturers of finished device parts or components, but such manufacturers are encouraged to use the appropriate provisions of this specification for guidance. Manufacturers of artificial blood and blood components are not categorized in this section, but should be included in section 606 of this chapter.