The basis of GMP certification is 2 1CFR820. 1 promulgated by the US government, which is also commonly known as QSR820 or GMP820. This quality system specification contains the requirements of current GMP. The requirements mentioned in this specification are the control of the design, production, labeling, storage, assembly and maintenance services of all finished instruments used in human body, as well as the equipment and control methods used in the above links. The requirements put forward in this specification are mainly to ensure the safety and effectiveness of finished devices, and at the same time meet the food, drug and cosmetic specifications (referred to as specifications). This specification establishes the basic requirements applicable to manufacturers of finished equipment. If a life-long product involves only a part of the links mentioned in this specification, but nothing else, then the manufacturer only needs to meet the requirements of its related fields mentioned in this specification. As far as the first-class instrument is concerned, its design is only suitable for 820.
. 30 (a) (2)。
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This specification does not apply to manufacturers of finished equipment parts or components, but such manufacturers are encouraged to use the appropriate clauses in this specification as a guide. Manufacturers of artificial blood and blood components are not included in this section, but should be included in section 606 of this chapter.