Decree 103 Good Manufacturing Practices On In Vitro Diagnostic Reagents

Good Manufacturing Practices on In Vitro Diagnostic Reagents
Part I Scope and principles
1.1 This document applies to in vitro diagnostic reagents that are managed in accordance with medical
devices.
1.2 This document is a special requirement for the quality management specifications for in vitro
diagnostic reagents.
Part II Special requirements
2.1 Personnel
2.1.1 In vitro diagnostic reagent production, technical and quality management personnel shall have
expertise in medicine, laboratory science, biology, immunology or pharmacy related to the products
produced, and have corresponding practical experience to ensure that they have ability to perform
duties in quality management.
2.1.2 All personnel working in clean rooms should be regularly trained in basic knowledge of hygiene
and microbiology, clean operations, etc. Persons who temporarily enter the clean rooms should be
instructed and supervised.
2.1.3 All personnel engaged in the production of in vitro diagnostic reagents, including cleaning,
maintenance, etc., should conduct professional and safety protection training according to their
products and the production operations they are engaged in.
2.1.4 Personnel cleaning requirements should be established and a clean room staff hygiene code
should be established. Personnel entering the clean room should be cleaned according to procedures,
and wear work caps, masks, clean overalls, work shoes. The operator who touches the product with
bare hands should disinfect the opponent again at regular intervals. The type of naked hand disinfectant
should be replaced regularly.
2.1.5 Personnel health requirements should be established, and personnel health records should be
established. Operators who are in direct contact with materials and products are inspected at least once
a year. Persons with infectious and infectious diseases are not allowed to work directly in contact with
the product.
2.1.6 Personnel clothing requirements should be clarified and management regulations for clean and
sterile work clothes should be established. Workwear and its quality should be compatible with the
requirements of the production operation and the level of cleanliness of the operating area. The style
and manner of wearing should be able to meet the requirements of protecting products and personnel.
Clean overalls and sterile overalls must not fall off fibers and particulate matter. Sterile overalls should
cover all hair, beards and feet, and retain body exfoliation.
2.2 Plants and facilities
2.2.1 There should be a clean production environment. The ground of the plant, the surrounding
environment of the road and transportation should not cause pollution to the production of the
product. The overall layout of the administrative, living and auxiliary areas is reasonable and may not
adversely affect the production area. The plant area should be kept away from contaminated air and
water sources.
2.2.2 The production plant shall be provided with facilities to prevent dust and insects from entering
other animals. The doors, windows and security doors of the clean room should be sealed, and the
doors of the clean room should be opened in a high cleanliness direction.
2.2.3 The production process in the clean room of the corresponding level should be determined
according to the production process control of the in vitro diagnostic reagent to avoid contamination
during production. The static pressure difference between clean rooms with different air cleanliness
levels shall be greater than 5 Pa, and the static pressure difference between the clean room and the
outdoor atmosphere shall be greater than 10 Pa, and there shall be means for indicating the differential
pressure. The pressure gradient between clean rooms of the same level should be reasonable.
2.2.4 enzyme-linked immunosorbent assay reagents, immunofluorescent reagents, immunoluminescent
reagents, polymerase chain reaction (PCR) reagents, gold standard reagents, dry chemical reagents, cell
culture media, calibrators and controls, enzymes, The preparation, dispensing, dispensing, filming,