On October 22-23, 2019 the third audit of EDQM - MJA 11/19 was conducted at the Central Laboratory for Analysis of Medicinal Products and Medical Products (the previous two were conducted in 2012 and 2016).
During the audit, the work of all departments of the Laboratory was thoroughly reviewed, related to the analysis of medicinal products, highlighted the strengths and recommendations for improvement.
The strengths were:
- IT tool (LIMS-CL computer program) for both the technical part and the QMS with specified functions, allowing comprehensive management of data on inconsistencies, internal audit, staff development, organization and analysis, etc .;
- Risk management system, which is implemented in different processes of activity of the mentioned laboratory;
- High level of competence of employees of the State Enterprise, in particular QA and IT departments;
- Methodology for the development, validation and verification of calculation forms (Excel forms), which takes into account the uncertainty of the analysis;
- Quality management system, which allows continuous improvement of laboratory processes;
- Staff training system;
- Internal qualification of most appliances and equipment.
State Enterprise "Central Laboratory for Analysis of Quality of Medicines and Medical Products"is one of the laboratories authorized by the State Service of Ukraine for Drugs and Drug Control to conduct independent quality control and safety of medicinal products in Ukraine, and the only one delegated by the State Service to represent Ukraine in the Pan-European network of official quality control laboratories for medicines in Europe (GEON).