In light of the recent authorisation issued by the Spanish Agency for Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios – AEMPS) for the mAbxience plant in León, we now explain how an audit is processed, drawing from the personal experience of the Quality Team at mAbxience León.
In order to obtain certification of compliance with good manufacturing practices (GMP) in Europe, you need to provide the national agency where the laboratory is registered with previously approved administrative and technical documentation, including data on the personnel in charge in the plant, plans of the facilities and the Site Master File. This includes industrial information on the facilities, process and control equipment, critical services, material and personnel flows, description of processes and the Quality Assurance system, demonstrating the adaptation thereof to the requirements of the European Medicines Agency (EMA). In this way, the National Agency acts on behalf of the EMA; thus its associated authorisations and certifications are applicable in all EU countries, as well as those which are party to the convention.
Once the basic documentation has been examined, the inspectors perform an on-site audit, examining the documentation and facilities associated with the manufacture, control, storage and shipping of products, as well as everything pertaining to the Quality Assurance System: staff training, equipment reviews, procedures for the purchasing and control of materials, controls on suppliers, validations of all types, characteristics of the products obtained, stability data, deviations, corrective and preventive actions (CAPA), etc.
Upon completion of the inspection, a report is drafted wherein the shortcomings encountered are classified into critical (which may result in the suspension of the authorisation), major and minor.
The laboratory under inspection is obliged to submit a detailed plan of corrective actions, with the corresponding implementation dates, which is evaluated by the inspecting agency. Once completed, and details of the corrective plan have been given, if the shortcomings are minor, the Agency issues an update of the authorisation and subsequently a certificate of compliance with GMP, wherein the scope thereof is stated. This certification must be renewed periodically.
Thus, the EMA guarantees potential clients of the laboratory under inspection that the company meets all necessary requirements and is authorised to conduct the activities described, which, in the case of mAbxiene León, include the manufacture and release of biological active substances and the release of biological and sterile medicinal products for human, veterinary and research use.