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STRUCTURING THE TRAINING AND QUALIFICATION OF TECHNICAL STAFF IN A PHARMACEUTICAL LABORATORY: AN APPROACH ALIGNED WITH ISO/IEC 17025:2017 REQUIREMENTS

European Statement

Patient Safety and Quality Assurance

Author(s)

Feriel El Kara1, Tarek Kamergi2, Raoua Souabni1, Sonia Sebai1, Kaouther Zribi3
1 : National Agency for Medicines and Health Products Tunis
2 : Bone Marrow Transplant Center Tunis
3 : Hygiene Laboratory Sfax

Why was it done?

Ensuring personnel competence is essential for the reliability of analytical results and for maintaining regulatory compliance in pharmaceutical control laboratories. In preparation for ISO/IEC 17025:2017 accreditation, the physico-chemical laboratory of the National Agency for Medicines and Health Products (ANMPS) needed to strengthen and formalize its training and qualification system to guarantee analytical quality and ensure the long-term sustainability of its management system.

What was done?

A comprehensive evaluation of the existing training and qualification practices was conducted, leading to the development of a structured and standardized framework covering training planning, competency assessment, and staff qualification. Improvement actions were proposed based on a diagnostic of current gaps.

How was it done?

The study took place from July to December 2024 and relied on three complementary approaches:
• Documentary analysis of procedures, training plans, and competency matrices;
• Semi-structured interviews with technical and supervisory staff;
• Direct observation of work practices in the laboratory.
A SWOT analysis was performed to identify strengths, weaknesses, opportunities, and threats, and to prioritize improvement measures. Targeted training programs were developed on critical analytical techniques (HPLC, spectrophotometry, dissolution testing), safety, and document management. A standardized qualification process integrating theoretical and practical assessments was also implemented.

What has been achieved?

The new system resulted in the deployment of all planned training and qualification activities, reaching a 100% implementation rate. The laboratory’s overall compliance rate increased from 39% to 68% after the adoption of the structured framework. The formalization of the process led to better harmonization of practices, improved technical proficiency, enhanced traceability of competencies, and reinforced team engagement through a participatory approach, contributing to a strengthened quality culture.

What next?

Future work will focus on sustaining this dynamic by integrating continuous competency monitoring, reinforcing advanced training on emerging analytical techniques, and developing digital tools for real-time tracking of qualifications. These actions aim to ensure sustained compliance with ISO/IEC 17025:2017 and to support continuous improvement of analytical performance within the laboratory.

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.

Which analytical method for parenteral nutrition mixtures dosing to choose? A regional comparative study

European Statement

Production and Compounding

Author(s)

Joan-Candy MABIN , Aïssé DIALLO, Hortense LANNELUC-BEAUJARD, Xavier DEVIOT

Why was it done?

The aim of this work is to find a cheaper alternative, reducing the analysis duration and allowing the pharmacy to be laboratory independent.

What was done?

The opening of the production unit (PU) leads to reorganize the parenteral nutrition mixtures (PNM) dosing. Primarily carried out in the biochemistry laboratory of our hospital, potentiometry and colorimetry analysis were long (more than an hour) and costly. PNM composition accelerates the aging of one of the device components that costs 1400 euros and have to be changed every 3 weeks, raising the total around 24300 euros per year only for this component.

How was it done?

Hospitals producing PNM in the region were identified and approached. They were asked about the type of dosed elements, the analysis method and the equipment used, about the analysis duration and localization (laboratory or pharmacy departments) and their overall cost estimation.

What has been achieved?

Five hospitals with different dosing equipment answered. Four of them analyze cations: calcium, magnesium, sodium and potassium by capillary electrophoresis, potentiometry or spectrometry, three of them analyze glucose by chromatography or colorimetry, and two of them determine osmolarity of the PNM mixtures. Dosages are performed by the pharmacy department in three PU where technician are required. Results are provided in about an hour when the activity depends on the laboratory and around five to ten minutes when it is managed by the pharmacy department. The average cost to purchase the equipment for each hospital was around 50000 euros (without the associated materials and the labour cost).

What next?

To conclude, no hospital interviewed can be a model because of either the high costs or the unadapted equipment size to the scale of the room of our PU. Nevertheless, during discussions, an equipment that might answer our needs was suggested, because no technician is needed for analysis, and it is described simple and easy to use. The manufacturer has been reached out asking for demonstration and information before any purchase. If accepted, the device will be qualified before going into production.