Distant Assessment leads to GMP Non-Compliance Report

Many GMP inspectorates have started performing remote inspections for selected sites for the duration of the outbreak of Covid-19.  In the EU for example, the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have agreed a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing facilities or other sites relevant for medicinal products in the EU. In an Q&A document, it is stated that for new sites/facilities, a "distant assessment" conducted by an EU/EEA competent authority may be an option. A GMP certificate may be then "granted depending on the outcome of the assessment".

In the EudraGMDP database, the Austrian Medicines and Medical Devices Agency has now published a Statement of Non-Compliance with GMP to the Austrian manufacturer Lupuca Pharma GmbH (Report No: INS-482723-12976686) based on a distant assessment. According to the company's websites, Lupuca Pharma specializes in the "contract manufacturing of niche products and medium batches in the pharmaceutical industry" and focuses on cosmetics and dietary supplements. For its activities, the company was holding a Manufacturing Authorisation, an authorisation of Distributor of Active Substance and a GMP certificate (all valid until 30 June 2020). The manufacturing authorisation was restricted to the manufacturing, quality control and distribution of certain products named in the document like for example a fever blister ointment, toothing suppositories, a rheumatism bath and certain dragées/ tablets.

The distant assessment leading to this Statement was conducted on 14 May 2020. In this assessment,  the company's CAPA plan was evaluated (based on observations from a previous inspection). The agency came to the conclusion that "major systemic deficiencies in the areas of supplier qualification, change management, deviation management, qualification of equipment, validation of computerised systems and good documentation practice could not be resolved". Based on "the knowledge gained during inspection of this manufacturer (…) it is considered that it does not comply with the Good Manufacturing Practice requirements". As a consequence, the Manufacturing Authorisation and the Authorisation of Distributor of Active Substance were completely revoked. A new GMP Certificate will not be issued.