[Translated article] Implementation of a traceability and safe drug preparation system in a clean room.

ABSTRACT

OBJECTIVE: To describe the process of implementing a traceability and safe manufacturing system in the clean room of a pharmacy service to increase patient safety, in accordance with current legislation. METHODS: The process was carried out between September 2021 and July 2022. The software program integrated all the recommended stages of the manufacturing process outlined in the "Good Practices Guide for Medication Preparation in Pharmacy Services" (GBPP). The following sections were parameterised in the software program personnel, facilities, equipment, starting materials, packaging materials, standardised work procedures, and quality controls. RESULTS: A total of 50 users, 4 elaboration areas and 113 equipments were included. 435 components were parameterized (195 raw materials and 240 pharmaceutical specialties), 54 packaging materials, 376 standardised work procedures (123 of them corresponding to sterile medicines and 253 to non-sterile medicines, of which 52 non-sterile were dangerous), in addition, 17 were high risk, 327 medium risk, and 32 low risk, and 13 quality controls. CONCLUSIONS: The computerization of the production process has allowed the implementation of a traceability and secure manufacturing system in a controlled environment in accordance with current legislation.