What is the mission of Inibsa's Quality Assurance department?
The core verb of the Quality Assurance department is to ensure. At Inibsa, our department’s mission is to ensure that users receive safe and effective treatment, which is why QA is involved in every process, from the arrival of raw materials and packaging components, to the release of the final batch. Our mission is to ensure compliance with quality standards, as well as with regulatory and client requirements throughout the entire product life cycle.
How do we ensure that all departments at Inibsa are aligned with the Quality Policy and Objectives?
This goal forms part of the company’s Vision. Inibsa’s Senior Management ensures that the Quality Objectives are aligned with the strategic and business objectives. We are all aware that our sector is highly regulated and that the regulatory framework is extremely stringent, as it protects the safety of end users. However, at Inibsa we have extensive knowledge and strong expertise to meet these requirements, while also adapting to the constant changes we face.
Which of the methods and actions used in the department do you consider key to ensuring efficacy and safety throughout the product’s life cycle?
Quality Assurance must ensure that the procedures and instructions describing all activities carried out at Inibsa are followed and kept up to date at the required intervals. This guarantees the standardisation of the processes and operations involved in manufacturing our products. Likewise, the analytical methods used to verify that products meet the required physicochemical specifications have also been validated to ensure that the product fulfils its intended use. In addition, our products undergo strict microbiological controls during the process and with the final product. All of this allows us to manufacture and control dental anaesthetics safely and ensure that the product delivers the efficacy for which it was designed. If we fail to comply with any procedure, instruction, method or specification, we must open a deviation.
What quality indicators or metrics do you use, and how do they help drive continuous improvement?
At the beginning of the year, the Quality indicators are established and their targets are presented to the Management Committee. Every month, they are monitored by the Quality Committee, which represents the entire industrial area. The indicators monitored each month are those that enable us to analyse the health and robustness of our Quality System. We track: customer complaints and their response times, the number of deviations, the effectiveness of the CAPA system, open and closed change controls, results from internal and external audits, confirmed OOS and OOT results, quality events linked to human error, etc. Each of these has a target. When setting these targets, we must take into account the principle of continuous improvement, as our system must become more robust year after year. If a target is not met, we must analyse and justify the reason why it is not being achieved, and open a corrective action to ensure the indicator is brought back under control. Carrying out this analysis and monitoring of the Quality System is essential; it is a key tool for demonstrating that our system improves continuously.
When a deviation arises, what is the process from detection to CAPA closure? What level of detail and follow-up is required?
Any employee may open a deviation whenever a breach of a procedure, instruction or specification is detected. The deviation must describe what happened, why, where, who detected the issue, when, and so on. In a deviation, investigation is crucial, as it will in most cases determine the root cause of the problem. Deviations are classified according to their criticality as minor, major or critical. The greater the criticality, the deeper the investigation. For major and critical deviations, recurrence must be prevented, so a corrective action will be established with the aim of eliminating the root cause. It is then important to assess the effectiveness of the corrective action over a period of time or a series of batches to ensure that the issue does not recur and compromise the quality of our product. We have set a maximum period of 30 days for closing a deviation.
What inspections have we passed in 2025?
This year we obtained Turkish GMP authorisation, a highly significant milestone for our business. Another inspection of particular importance was the one carried out by the Russian authorities, which we passed in July. We have a major market in the Eurasian Union, so it was vital for INIBSA to complete it successfully. It was quite an experience: two inspectors in the same room covering different topics, two interpreters, and a large number of points to address. Many colleagues had the opportunity to take part, and the organisation and preparation of documentation with virtually no waiting times were essential. The outcome was very positive. Also in July, we underwent the Pharmacovigilance inspection by the regional government of Catalonia. It was an intense week due to the rigour and deep knowledge and detail of the inspection. The result was again positive, and a comprehensive CAPA Plan has been drawn up and is already underway. In July this year, we also renewed our manufacturing authorisation following the installation and commissioning of the new L6 dosing line.
What role do you think the Quality Department will play in Inibsa's future strategy?
The Quality Assurance Department will be a key pillar in Inibsa’s growth and transformation. As the company prepares to significantly increase its production of dental anaesthesia cartridges by 2029, our commitment to excellence will be more important than ever. As global leaders in dental anaesthesia, our products, processes, facilities and equipment must not only meet but exceed the most demanding standards. Customer audits and inspections are becoming increasingly rigorous, and we are ready to respond with confidence, strength and foresight. Our team is evolving towards a culture of efficiency, individual accountability and genuine collaboration. We are strengthening internal communication and defining clear, automated quality and performance indicators to ensure agile, accurate and proactive monitoring. This transformation will allow us to anticipate challenges and make smarter, more strategic decisions. Quality Assurance not only safeguards Inibsa’s present: it is shaping its future with innovation, commitment and excellence.
