CSV with GDP

Good Distribution Practice (GDP)

GDP standard (English: Good Distribution Practice) - This standard establishes the requirements for good distribution practice (wholesale sales) of medicines, medical equipment and medical devices

GDP rules include:

requirements for the quality assurance system for storage and transportation of medicinal products
personnel requirements
requirements for premises and equipment for storing medicines
requirements for documents for storage and transportation of medicines
requirements for the actions of the subject of circulation of medicinal products for storage and transportation
requirements for the transportation of medicines
requirements for containers, packaging and labeling of medicinal products
requirements for validation of computer systems (CS)
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18. A system that replaces the separation of storage areas, including through electronic data processing, must provide the required level of security and be validated.

23. The results of temperature mapping are recorded in a special log (card) on paper and (or) electronically daily, including on weekends and holidays. The registration log (card) is stored for two years.

29. Racks (cabinets) for storing medicinal products must be labeled, have rack cards located in the visible area, and ensure the identification of medicinal products in accordance with the accounting system used by the subject of medicinal products circulation. It is permissible to use an electronic data processing system instead of rack cards. When using an electronic data processing system, identification using codes is allowed.

30. Medicines for which the subject of circulation of medicines has not made a decision on further circulation, or medicines whose circulation has been suspended, as well as medicines returned to the subject of circulation of medicines must be placed in a separate room (zone) or isolated using a system electronic data processing providing separation.

37. Equipment used in the process of storage and (or) transportation of medicines includes, but is not limited to:

a) air conditioning systems; b) refrigeration chambers and (or) refrigerators; c) security and fire alarm systems; d) access control systems; e) ventilation system; f) thermohygrometers (psychrometers) or other equipment used to record temperature and humidity.

49. Medicines are placed in rooms and (or) areas for storing medicines in accordance with the requirements of regulatory documentation and (or) the requirements specified on the packaging of the medicine, taking into account:

c) method of administration of drugs. When placing medicinal products in premises and (or) areas for storing medicinal products, the use of computer technologies is allowed (alphabetically, by code).