IMPLEMENTATION OF A TECHNICAL PLATFORM IN A PHYSICOCHEMICAL CONTROL LABORATORY : OPERATIONAL OUTCOMES AND FUTURE OPTIMIZATION
European Statement
Patient Safety and Quality Assurance
Author(s)
B.Ben Houria, F.ElKara , M.Ben Messaoud, M.Bizid, A.Tabbabi, S.Gmati
Why was it done?
Improving the performance of quality control laboratories is crucial to ensure the quality, safety and regulatory compliance of medicines. Ongoing challenges, including fragmented workflows and limited traceability, highlighted the need for a structured and harmonized operational model. To address this, a technical platform was established within the physicochemical control laboratory of a National Agency for Medicines and Health Products to consolidate resources, streamline work organization and align analytical activities with international standards and best practices.
What was done?
A technical platform was implemented to reorganize analytical activities, restructure laboratory areas by function and strengthen quality assurance practices. The initiative included assessing the existing system, defining functional analytical zones (e.g. spectroscopy, High Performance Liquid Chromatography (HPLC)…), optimizing equipment allocation and appointing an equipment manager to coordinate scheduling, oversee maintenance and ensure operational traceability. Then, a performance evaluation matrix was developed and applied to objectively assess the effectiveness of the newly implemented technical platform and identify areas requiring further improvement.
How was it done?
This descriptive and comparative study combined documentary analysis, on-site observation and review of international guidelines. The methodological approach comprised three steps:
1-Assessment of the existing system : Review of the laboratory’s organization, equipment, analytical processes and human resources to identify factors influencing overall performance.
2-Structuring of the technical platform and performance evaluation: Organization by instrument specialization and the use of structured matrix.
3-Comparison with international standards : Scientific literature and reports from European reference laboratories were reviewed to benchmark the implemented technical platform against international standards.
What has been achieved?
The platform was implemented in July 2025 through a spatial and functional reorganization that improved methodological coherence, reduced unnecessary sample manipulation and increased equipment utilization. The designation of an equipment manager contributed to better planning, coordinated instrument scheduling and enhanced workflow oversight, thereby reinforcing operational continuity. Performance matrix results indicated satisfactory compliance across key domains: infrastructure (100%), human resources (50%), equipment (75%) and quality assurance (50%). These outcomes confirm the solid implementation of the technical platform while highlighting the need to strengthen documentation, staff training and performance monitoring.
What next?
Future developments will focus on digital integration through paperless analytical workflows, automated test scheduling and real-time electronic traceability to enhance data integrity and predictive performance analysis. Gradual introduction of artificial intelligence, while respecting regulatory data confidentiality, offers promising opportunities to predict analytical deviations, optimize equipment use and improve resource management. Ongoing monitoring of Key Performance Indicators (KPIs) and continuous staff development will be essential to maintain and sustain long-term performance improvements.
Implementation of a tool for annual quality assessment of drug information provided by hospital pharmacies
European Statement
Clinical Pharmacy Services
Author(s)
Dorothea Strobach, Ute Chiriac, Sigrun Klausner, Claudia Langebrake, Christiane Querbach, Carolin Schuhmacher
Why was it done?
Although guidelines for DI demand regular quality assurance procedures, no method of evaluation is internationally agreed on. The tool should be feasible, reproducible and reflect real-life quality of DI. It should allow to identify areas for quality improvement in general and for every participant.
What was done?
We developed a tool for annual quality assessment of drug information (DI) provided by hospital pharmacies on behalf of the German Association of Hospital Pharmacists ADKA e.V.. The tool has been successfully implemented for four years.
How was it done?
We developed a new tool for quality assessment of DI using a fictitious test enquiry and simulated real-life conditions and proved it representative for real-life quality [1]. The answers for the test enquiry are evaluated by blinded experts for content and formal requirements. For four years, 2017-2020, annual assessment of DI was offered to German language hospital pharmacies with changing topics and enquiry levels. Participants receive their own result in comparison to average of all regarding content-related and formal requirements. A proposal for an answer is published afterwards for educational purposes.
What has been achieved?
The annual DI quality assessment tool was successfully implemented as shown by increasing numbers of participating hospital pharmacies (45/71/79/118). Areas for improvement have been identified in general and can be identified by each participant as well. As an example, presentation of references has improved over the years [2]. Since 2018, a certificate of participation is offered as document for quality assurance audits thereby underlining the importance of this hospital pharmacy service.
What next?
Annual quality assessment for DI by hospital pharmacies will be further offered. Results over years will be evaluated for overall effect of the annual test tool on quality improvement regarding content-related and formal requirements. This method for annual quality assessment of DI provided by hospital pharmacies could be implemented by other countries.
References
1. Strobach D et al. EJHP 2020 online ahead of print. doi: 10.1136/ejhpharm-2020-002409
2. Strobach D et al. Krankenhauspharmazie 2020;41:187-91