EAHP represents over 30,000 hospital pharmacists across 37 member countries. EAHP represents and develops the hospital pharmacy profession within Europe in order to ensure the continuous improvement of care and outcomes for patients in the hospital setting. This is achieved through science, research, education, practice, as well as sharing best-practice and responsibility with other healthcare professional
The EAHP Board, elected for three-year terms, oversees the association’s activities. Comprising directors responsible for core functions, it meets regularly to implement strategic goals. Supported by EAHP staff, the Board controls finances, coordinates congress organization, and ensures compliance with statutes and codes of conduct.
The EAHP staff supports the Board in executing EAHP’s mission. The Staff assists in financial management, events organisations, policy activities and all EAHP projects. The EAHP staff works closely with EAHP’s members and ensures the effective communication all relevant stakeholders.
The first member countries were Belgium, Britain, Denmark, France, the Federal Republic, Germany, Italy and The Netherlands in 1972. EAHP has now 36 EAHP members and 2 Associate Members. EAHP is open to countries members of the Council of Europe and since 2022 to organisations representing the interests of hospital pharmacists from outside the Council of Europe (Associate Membership)
EAHP’s structure is also composed by different standing committes: EAHP Scientific Committee, EAHP Education Executive Committee and the EAHP CTF Steering Committee.
At EAHP, we are committed to transparency in our governance, ethical standards, and funding practices. This section provides open access to our foundational documents, including the EAHP Statutes, Code of Conduct, and Funding Sources. By sharing these resources, we aim to uphold accountability and foster trust with our members, partners, and the public.
Keep up with all EAHP’s events and webinars. Contact the team at info@eahp.eu should you have any questions about upcoming events or activities.
Here you can find all upcoming events organised by EAHP and by all its members and associate members. Do not hesitate to contact the events team at events@eahp.eu should you have any questions about the organisation of these events.
Hospital pharmacists conduct a critical role in the care of patients in hospitals. Learn more about what they do here and in all the pages under Hospital Pharmacy practice and Policy.
Self-Assessment
SILCC
Closed SIGs
EAHP brings together experts from many areas of hospital pharmacy practice providing and highlighting good local sustainable practices as that can be up-scaled and shared with other countries. The EAHP Working Group on Sustainability has the aim of reducing the environmental burden of the hospital pharmacy services.
The European Association of Hospital Pharmacists (EAHP), and its 36 member country platforms are creating a Common Training Framework for the hospital pharmacy education in Europe. The goal of this project is to allow the free movement of hospital pharmacists within the European Union.
The European Association of Hospital Pharmacists (EAHP) and the European Society of Clinical Pharmacy (ESCP) have collaboratively developed the Oath to Society. The Oath to Society is all encompassing and acts as a contract for excellence in providing compassionate patient care, working as part of the healthcare team and advancing the pharmacy profession, and showcasing how clinical and hospital pharmacists work every day
A day created to highlight the importance and to celebrate the work done by hospital pharmacies. This day celebrates all hospital pharmacy teams.
The Early Career Network aims to empower early-career pharmacists by sharing opportunities, insights, and success stories from across 25 member countries.
Together, we’re building a stronger, more connected hospital pharmacy community: one story, one country, one pharmacist at a time.
Catch up with EAHP’s press releases
Find all EAHP relevant publication like the EAHP Surveys, annual reports and the history books.
The European Journal of Hospital Pharmacy (EJHP) is the only official journal of the European Association of Hospital Pharmacists (EAHP) and is committed to advancing the science, practice and profession of hospital pharmacy. As the premier communication platform for hospital pharmacists worldwide, EJHP is a major source for continuing education as well as updates on advances in the practice and standard of pharmaceutical care for patients.
When EAHP and Hospital pharmacists appear in the news.
EAHP publishes a monthly EU monitor with updates about the latest EAHP initiatives and information relevant for the hospital pharmacy profession.
The Sponsor Channel is designed to maximise visibility and engagement, allowing sponsors to connect with the hospital pharmacy community and partners in a dynamic and interactive environment. From product demonstrations to networking sessions, the Sponsor Channel offers a range of opportunities for sponsors to showcase their offerings and generate leads in the new EAHP Website.
Patient Safety and Quality Assurance
E. WILLIAM1, K. TLILI1, L. WANG1, A. TARRE1, A. BENOMAR1, M. EL HUSSEINI1, S. OUABDELKADER2, I. DEBRIX1, F.FEDERSPIEL1
1 : HÔPITAL TENON, PHARMACIE À USAGE INTÉRIEUR, PARIS, FRANCE.
2 : HÔPITAL TENON, DIRECTION QUALITÉ ET GESTION DES RISQUES, PARIS, FRANCE.
Medication reconciliation (MR) is a widely recognized process for preventing medication errors (ME). However, the step involving the preparation of the” Best Possible Medication History (BPMH) is a complex process, itself subject, like any production process, to potential errors. This means that inaccurate or incomplete BPMHs can be generated, in contradiction with the high level of reliability implicitly expected of the final product. However, to our knowledge, current recommendations do not describe a dedicated risk management model for this process, and published studies addressing ME potentially induced by MR itself are scarce.
The aim of this work was to consider the BPMH preparation process as a full-fledged production process and, as such, to develop a dedicated safety model by identifying potential or previously described error risks, existing safety measures, and actions to be implemented within a continuous quality improvement framework.
A systemic analysis method, FMECA (Failure Modes, Effects, and Criticality Analysis) was chosen to collectively assess the relative criticality of each identified risk, with the aim of establishing specific safety principles for this process.
Seven analysis meetings took place over six months, bringing together 3 to 5 senior pharmacists, 1 to 3 junior pharmacists, and one quality manager. The analysis identified 49 generic hazards and 62 associated risks. The most critical risks were related to identity vigilance, the completeness and reliability of sources used, the specificity of high-risk drugs, data recording, and the pharmacotherapeutic consistency of the final BPMH. Discussions confirmed the role of common cognitive biases in the occurrence of potential, often overlooked errors. The proposed safety system therefore mainly focused on strengthening awareness of typical error risks during MR, formalizing a self- and double-check checklist, and developing a dedicated non-conformity reporting form.
This systemic analysis contributed to a collective awareness of the persistent risk of errors in a process that may appear, at first glance, to be well controlled. The analysis of non-conformities through a dedicated experience feedback committee (CREx) will confirm the value of a dynamic and collective approach in the more global management of errors in clinical pharmacy.
Patient Safety and Quality Assurance
Cristina Garcia Fernandez, Estela Alamino Arrebola, Bárbara Lopez Bautís, Carmen Gallego Fernandez, Begoña Tortajada Goitia.
Patient safety in clinical trials relies on the correct management of both investigational and auxiliary/comparator medications. While investigational products are usually managed through automated systems (e.g., IWRS) ensuring traceability and standardization, auxiliary medications often lack similar oversight from sponsors. A preventable medication error in an oncology clinical trial—caused by the preparation of an incorrect drug concentration due to the absence of automated supply and harmonization—highlighted the need to analyze system gaps and implement corrective actions to strengthen patient safety and medication traceability.
A Root Cause Analysis (RCA) was conducted following the detection of a medication error involving the preparation of hospital stock (20 mg/mL) instead of the clinical trial formulation (10 mg/mL). The objective was to identify systemic weaknesses and design a Corrective and Preventive Action (CAPA) plan aimed at preventing recurrence and improving management of auxiliary medication in clinical trials.
The RCA was performed in July 2025 using the “5 Whys” methodology, supported by:
-Document review, staff interviews, and chronological reconstruction of the event.
-Analysis of human, technical, communicative, and organizational factors.
-Classification of the incident (NCC MERP category D — no patient harm).
Corrective measures implemented included:
– Creation of a pre-trial pharmacy checklist to ensure drug availability and concentration verification.
– Mandatory pharmaceutical validation after any protocol amendment.
– Formal requests to sponsors to standardize drug concentrations across sites.
– Improved communication channels between sponsors, pharmacy, and clinical teams
-Identification of the main root cause: lack of automation in auxiliary drug supply requiring manual requests.
-Prevention of similar future events through harmonized pharmacy processes.
-Reinforcement of patient safety culture and traceability of clinical trial medications.
-Strengthened collaboration among hospital pharmacy, clinical teams, and sponsors.
-No patient harm resulted from the event, confirming the importance of early detection and system review.
-Extend IWRS automation and standardization practices to include auxiliary medications in all clinical trials.
-Share the initiative with other hospital pharmacies and sponsors to promote harmonization at institutional and multicenter levels.
-Continue monitoring the implemented CAPA and evaluate its impact on error prevention.
-Foster continuous improvement in pharmacy oversight and communication workflows for clinical research.
Patient Safety and Quality Assurance
Khalil MEDDINE, Yasmine EL YOUSSOUFI, Madiha ALAMI CHENTOUFI, Houda ATTJIOUI, Driss TANANI, Abdelhafid BENOMAR
To identify performance gaps and critical points within the sterile and implantable medical device circuits, with the aim of guiding targeted improvements and ensuring safer, more reliable management of these devices.
A multidisciplinary self-assessment of the sterile and implantable medical device circuits was carried out using the Interdiag DMS® evaluation tool.
The evaluation was conducted using the Interdiag Excel file, which includes dedicated modules for sterile and implantable medical devices. The analysis focused on the tool’s implementation, the objectives of the self-assessment, the resulting action plans, and feedback obtained throughout the process.
The assessment highlighted strong performance in information systems and traceability for implantable devices, but weaknesses were identified in their documentation management. For sterile medical devices, major deficiencies were observed in quality management, transport, and return/disposal processes (10–20% compliance), while pharmacy premises and demand management showed moderate performance (50–60% compliance). These findings allowed for the implementation of targeted corrective actions.
The findings will guide ongoing targeted improvements, enhance coordination among healthcare stakeholders, and foster a sustainable culture of quality and safety in medical device circuits.
Patient Safety and Quality Assurance
Arce Sánchez, M; Álvaro Alonso, EA; Barrueco Fernández, N; Prieto Román, S; López Guerra, L; Sánchez Lorenzo, M; Flox Benítez, MP; Escobar Rodríguez, I.
Accurate weighing of raw materials(RM) is a fundamental step in ensuring the quality and safety of compounding in a pharmaceutical laboratory(PL).
Implement the use of standard masses(SM) to ensure that RM weighings performed in the PL analytical balance are as accurate as possible.
1.Balance employed is class I, with special accuracy, precision 1mg, and weighing range 10mg-220g. For this reason, E2 SM were purchased in accordance with the classification of the International-Organisation-Legal-Metrology(OIML). SM were calibrated by a laboratory accredited by the National-Accreditation-Entity(ENAC), stored under the same conditions as the balance, and handled according to manufacturer’s instructions.
2.A sensitivity test was performed to measure accuracy. The USP and chapter of the European-Pharmacopoeia, establish that the SM must be between 5% and 100% of the maximum weighing capacity of the balance. The test is satisfactory when the result obtained is within 0.1% of the nominal value(control-limit). An alert-limit was also establish(calculated as half control-limit).
3.A record form, standard-operating-procedure(SOP) and working circuit were designed. Before weighing RM, the pharmacy technician(PT) must verify leveling and internal calibration; weigh the selected SM, and record the result.
4.If weight is outside any limits, repeat internal calibration and weigh again. If it remains outside the alert-limit, the balance can be used, but the pharmacist must be notified to request external calibration. If it exceeds the control-limit, the balance cannot be used, and external calibration must be requested while another balance is employed.
SM acquired were: 10mg,20mg,20g,50g, and 100g. Those chosen to perform the sensitivity test were 20g and 100g(9.09% and 45.45% of maximum weighing balance capacity).
The range defined for 20g SM was 20g±20mg. Control-limit was 20g±10mg(19.990g-20.010g) and alert-limit was 20g±5mg(19.995g-20.005g).
The range defined for 100g SM was 100g±100mg. Control-limit was 100g±50mg(99.950g-100.050g) and alert-limit was 100g±25mg(99.975g-100.025g).
Since it was implemented in January-2025, all weighings have remained within the range.
The use of SM has shown to be a satisfactory circuit in ensuring the accuracy of the weighing of RM, used in the preparation of pharmaceutical compounding, thereby guaranteeing their safety and quality. This circuit could be established in other pharmacy departments.
Patient Safety and Quality Assurance
Elisabetta Volpi, Hospital Pharmacy, Ospedale del Cuore, Fondazione Toscana Gabriele Monasterio;
Irene Benassi, Specialisation school in Hospital Pharmacy, University of Pisa;
Sara Tonazzini, Hospital Pharmacy, Ospedale del Cuore, Fondazione Toscana Gabriele Monasterio;
Giuseppa Lo Surdo, Hospital Pharmacy, Ospedale del Cuore, Fondazione Toscana Gabriele Monasterio;
Mario Cossu, Information systems and information technologies, Fondazione Toscana Gabriele Monasterio
Maurizio Mangione, Information systems and information technologies, Fondazione Toscana Gabriele Monasterio
Mattia Lorenzini, Nursing, Technical and Rehabilitation Service, Fondazione Toscana Gabriele Monasterio;
Stefania Baratta, Nursing, Technical and Rehabilitation Service, Fondazione Toscana Gabriele Monasterio;
Pierantonio Furfori, Anesthesia and Resuscitation Unit, Ospedale del Cuore, Fondazione Toscana Gabriele Monasterio;
Paolo Del Sarto, Anesthesia and Resuscitation Unit, Ospedale del Cuore, Fondazione Toscana Gabriele Monasterio;
Stefania Biagini, Hospital Pharmacy, Ospedale del Cuore, Fondazione Toscana Gabriele Monasterio.
Most preventable adverse events occur during medication use, especially with intravenous (IV) drugs requiring preparation before administration. Furthermore, for infusions, proper labelling is critical to reduce the risk of medication errors.
Our hospital has used an electronic therapeutic record (eSTU) for over 10 years. In 2020, a multidisciplinary team of anesthesiologists, pharmacists, nurses and health IT specialists developed a dedicated module to ensure traceability of drug prescribing and administration in the operating room, focusing on cardiac surgery. At the same time, infusion syringe labelling evolved from handwritten to computerized labels, improving safety and traceability. This study aimed to assess impact of a standardized electronic prescribing and labelling system.
All standardized IV prescriptions issued during cardiac surgeries between 2021 and June 2025 were included in the analysis. Prescriptions were categorized by administration mode (bolus or infusion) to assess healthcare professionals’ adherence to the standardized prescribing system. A qualitative evaluation of labels applied to infusions was also performed.
The standardized prescription system was used in 5.272 procedures (4.542 adults; 730 pediatric), averaging 1.009 adult and 162 pediatric surgeries per year. A total of 93.291 prescriptions were recorded (81.861 in adults, 18 per procedure; 11.430 in pediatric cases, 16 per procedure), with a progressive increase from 18.211 prescriptions in 2021 to 20.955 in 2024 (+15.1%). These results confirm the system’s usability and effectiveness of staff training. Qualitative analysis of labelling practices initially showed syringe labels were handwritten and included limited information (e.g., drug name, concentration). With the computerized system, printed labels now contain detailed data: drug name, identifying code, dose, diluent, concentration, preparation date and time.
Our data demonstrate, for the first time, that the adoption of a standardized prescription system in cardiac surgery is an effective strategy, offering a fast, safe and user-friendly approach. Furthermore, computer-generated labelling ensures complete traceability and reduces the risk of medication errors.
Growing adoption of standardized prescription in both adult and pediatric cardiac surgery confirms its feasibility in high-complexity settings. Extending this system to other surgical areas (e.g., Gynecology, Hemodynamics, Electrophysiology) may further enhance medication safety across the hospital.
Patient Safety and Quality Assurance
L. DE AGUSTIN SIERRA, P. FLOX BENITEZ, B. MONTERO PASTOR, A. SUCH DIAZ, P. TEJEDOR PRADO, E.A. ALVARO ALONSO, E. IZQUIERDO GARCIA, N. FONT TARRES, M. SANCHEZ LORENZO, I. ESCOBAR RODRIGUEZ.
Medication dispensing errors were detected more frequently in our Pharmacy Department. This errors were related with procedures among pharmacy technicians (PT).
Formation programs bettween PT are implemented in our Pharmacy Department in other critical areas such as compounding or cytotoxic drugs but not dispensing.
It its known that a lack of knowledge of established work procedures among pharmacy technicians (PT) can contribute to a potential increase in medication dispensing errors. On the other hand, medication dispensing errors are preventable incidents in the process of distributing and administering drugs that can cause avoidable harm to patients.
Implementation of a procedure manual to define operative procedures carried out by PT that need improvement in the safe dispensing medications and establish appropriate measures for safer and efficient work.
Observational, prospective, descriptive study conducted by pre and post survey (1-5) during July and september 2025 among PT. The total number of surveys was 28 (15 pre and 13 post).
A structured questionnaire was developed with closed question (pre and post) about: (1) medication distribution and dispensing, (2) knowledge of stablished operative procedures, (3) clinical pharmacy services and medicine information, (4) personal abillities and skilss and (5) necesity for training and information.
Surveys included 11 questions using Google Forms Likert scale of 1-5, being 5 maximum score.
Post-survey was conducted after three-months period training for PT.
In pre-survey, medication distribution and dispensing received the lowest score (3 on five-point scale). The rest of responses showed a satisfaction degree (4) also for necesity for training and information.
After manual implementation, post-survey questionnaire shows that manual enhanced work procedures and medication distribution, dispensing (3 pre Vs 4 post), self-confidence and autonomy in established procedures. (4 on five-point scale). Moreover, overall satisfaction about was satisfied (4).
The implementation of a procedure manual has enhanced generally satisfied between PT. Although our survey shown this enhances, we are conscious about importance and necessity of reglated formation in Pharmacy Department in order to safe dispensing medications and safer and efficient work. For that reason, reglated formation has been scheduled among PT.
Patient Safety and Quality Assurance
Javier Mata Alonso, Paula Ruiz Briones, Carlos Jiménez Villarón, Andrés Prado Lozano, Gonzalo Domínguez Chaparro, David Samitier Samitier, Juan Manuel Montes Gómez, Félix García Moreno, Sagrario Pernía López, Ana Herranz Alonso, María Sanjurjo Sáez
Concomitant use of ophthalmic drugs and contact lenses (CL) is frequent in clinical practice. However, product data sheets usually provide limited or unspecific guidance regarding compatibility. This information gap may lead to inappropriate use, discomfort, or ocular toxicity. Pharmacists can play a key role in ensuring safe use through structured, evidence-based counselling. This initiative was developed to identify existing safety gaps and to establish practical recommendations for clinical decision-making.
A review was conducted of ophthalmic drugs authorised and marketed in Spain to determine available information on their compatibility with CL. The objective was to compile regulatory data, identify inconsistencies, and design a reference framework of recommendations for pharmacists advising patients who use CL and require topical ocular treatment.
Data were obtained from the CIMA database (Spanish Medicines Agency). Among 301 registered eye drops, 186 were authorised and marketed. Products containing benzalkonium chloride (BAK) were excluded due to known incompatibility. The remaining 96 formulations (52 unique presentations) were reviewed using technical data sheets (sections 4.4 and 6.1) and compared with evidence from clinical guidelines and major ophthalmology literature. Information was synthesised into practical counselling recommendations.
Most data sheets lacked clear guidance. Three patterns were identified: no mention of CL, a generic 15-minute delay, or explicit contraindication. Only two products (bilastine 6 mg/mL and sodium chloride 0.9%) explicitly allowed CL use. Based on pharmacological class, evidence-based recommendations were developed to guide pharmacists in advising patients on safe CL use with ophthalmic drugs.
This practice model is ready to be implemented in hospital pharmacy services. Future steps include incorporating the recommendations into clinical protocols, developing patient information materials, and collaborating with ophthalmology departments to enhance safety and consistency in pharmaceutical counselling.
Patient Safety and Quality Assurance
Francesca Cammalleri, Giorgia Bo, Roberta Cutaia, Maria Laura Savi
This project was initiated to institutionalize auditing as a standard, effective quality and safety tool. Our motivation was twofold, reflecting our commitment to patient care: first, to define and standardize audit procedures consistent with UNI EN ISO 9001; second, and most critically, to ensure safety action by verifying that correction plans drive real, measurable changes in medicine management, directly enhancing patient safety on the wards
Between January 2024 and March 2025, a total of 14 structured internal audits were conducted. The verification cycle systematically assessed quality and safety compliance using a specific Checklist (incorporating UNI EN ISO 9001 requirements) and targeted inspection tools for pharmaceuticals specific areas. All findings and critical issues were formally documented in the ‘Internal Audit Report’ to ensure official follow-up
The auditing process utilized a systematic, structured approach. After distributing the comprehensive annual audit plan, verification was conducted using a checklist integrated with UNI EN ISO 9001 requirements. Recognizing drug management risks, pharmacist managers utilized the ‘Department Ward Cabinets Inspection Report’ for in-depth checks on storage conditions and restricted access. Findings were consolidated in the ‘Internal Audit Report’, initiating a resolution phase where minor non-conformities were resolved immediately, while others were formally scheduled for verified follow-up during the subsequent 2025 inspection cycle
The assessment established a high level of safety compliance, with all audited units demonstrating full compliance regarding optimal storage conditions and restricted access. Crucially, the audit cycle proved effective in identifying high-risk issues: three units were flagged for failing to separate narcotic drugs and concentrated potassium solutions, alongside two units maintaining excessive drug stock. Only one major non-conformity was identified across all units. This systematic approach resulted in a clear, actionable plan for continuous quality enhancement
The program is undergoing systematic follow-up and has led to immediate expansion: audits are continuing into 2025, with verification cycles already initiated in new, complex areas like surgical units. Furthermore, we have scheduled the full revision and update of the Pharmaceutical Management Document by the end of 2025. This continuous audit cycle is now a permanent cornerstone of our Quality System, driving sustained improvement and formal policy reinforcement
Patient Safety and Quality Assurance
A. VARAS PEREZ1, MJ. LOPEZ MUÑOZ1, C. RODRIGUEZ MORETA1.
1HOSPITAL SERRANIA DE RONDA, FARMACIA, RONDA, SPAIN.
Long-acting injectable antiretroviral therapy represents a major advancement in HIV management. This method of administration is novel, and as such, a process must be defined that involves different healthcare professionals and that must provide the patient with the training related to the administration in the best way. The intramuscular combination of cabotegravir and rilpivirine (CAB/RPV IM) offers an alternative to daily oral regimens, potentially improving adherence and patient quality of life. To ensure safe and efficient implementation, a multidisciplinary protocol was developed in a primary hospital.
A coordinated protocol was established for the prescription, validation, dispensing, and administration of CAB/RPV IM, involving hospital pharmacy, nursing, and medical teams. Outcomes were assessed after one year of implementation.
A retrospective, cross-sectional descriptive study was conducted, analyzing CAB/RPV IM administrations recorded since March 2024. Inclusion criteria included virologic suppression, stable oral regimen, absence of resistance mutations to CAB/RPV, no hepatitis B coinfection, and patient commitment to scheduled visits. Electronic prescribing via Farmatools® triggered appointments with pharmacy and nursing. Pharmacists provided individualized care and scheduled doses within the ±7-day window, aligned with nursing availability. Patients received automated email reminders; missed appointments prompted follow-up calls. Delays beyond seven days were reported to the physician. Data on administration dates, discontinuations and reasons, viral load, and dosing intervals were extracted from the External Patient Module PRISMA and electronic health records.
A total of 518 doses were administered to 138 patients. Nine patients (6.5%) discontinued treatment due to adverse effects, personal/work conflicts, pregnancy, anticoagulation, or lack of appropriate needles. No virologic failures occurred. All doses were administered within the ±7-day window (mean deviation: -1.9 ± 2.0 days). The average number of doses per patient was 3.6 (range: 1–7). Nursing intervened in 4.5% of follow-up visits due to missed appointments. Email reminders reached 81.9% of patients. The protocol enabled integrated care, improved adherence, and ensured safe delivery of CAB/RPV IM therapy.
Expansion of the protocol to new candidates is planned, along with enhanced interprofessional coordination and digital tools for active follow-up. This experience may serve as a model for other centers implementing CAB/RPV IM in HIV care.
Patient Safety and Quality Assurance
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
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.
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.
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.
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.
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.
