THE FDA CERTIFIES THE QUALITY OF IBSA FARMACEUTICI: A GUARANTEE OF VALUE FOR PATIENTS20 July 2022
From research to production, from packaging to logistics, from general to administrative services: IBSA Farmaceutici ensures impeccable quality standards in every area of its operations, all guaranteed by control procedures and certifications obtained from the competent Authorities.
Quality control and the maintenance of these standards are very important for the company, because they are part of a process that requires constant attention, accurateness and a rigorous daily commitment.
IBSA Farmaceutici has been very recently subjected to an inspection by the FDA (Food and Drug Administration), the Regulatory Authority that approves the marketing of drugs and medical devices in the United States.
The FDA audit was aimed at evaluating – and then confirming – the Marketing Authorisation for a medical device based on hyaluronic acid in a syringe-vial for intra-articular use, produced in the Lodi plant and exported by IBSA to the American market.
The inspection conducted by the FDA experts focused on all the steps necessary for the production of the medical device: from the adequacy of the technical systems to the completeness of the entire structure of the quality system; from the analysis of the microbiological components to the environmental conditions, that not only concern hygiene aspects, but also the sterile conditions of the premises. The continuous and supervised monitoring processes were also examined, up to the verification of the expertise, competence and professionalism of all the operators involved in the process.
“The FDA audit was concluded without any Form 483, any non-compliance and any recommendation. This means that we are perfectly aligned with the requirements of the American legislation; indeed, we have also received the congratulations of the inspectors for the work we do”, commented Paola Emaldi, Senior Quality Assurance Manager at IBSA Farmaceutici. “We supported the inspectors with great attention and thoroughness, and this outcome is due to both the teamwork and the whole system of analysts, operators, laboratories, technical and production services. Quality is in our way of doing things; it permeates all the activities of the facility and animates the work of this fine team”.
That was not the first inspection we have had. The FDA controls, in fact, began in 2015 and are carried out every two years, in order to constantly assess quality performance. Over time, IBSA has managed to establish itself as a virtuous company, which acts in total compliance with every necessary requirement across the entire production process, from the design of the plant to the regulatory documentation.
“We have built our good reputation and our reliability over time, documenting with facts the solidity and robustness of the IBSA Quality System, as well as the competence of all our collaborators. Continuing to consolidate our good relations with the Regulatory Authorities – which are in charge of protecting public health in their own territory – is also very important, also considering the company’s future growth opportunities on foreign markets”, concluded Emaldi.