14/15 June 2022
The European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have agreed on 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 European Union.
One interesting outcome created is the questions and answers document on regulatory expectations for medicinal products for human use during the covid-19 pandemic, which is planned to be frequently updated. In the first revision the four new questions and answers, 2.2, 2.3, 2.4 and 4.1 were added.
Question and Answer 2.2 deals with GMP certificates and manufacturing/import authorisations. Due to the current difficulties in carrying out GMP inspections on site, it is often not possible to extend GMP certificates accordingly. However, this should now be possible in order to avoid difficulties in the availability of medicines - until the end of 2021. The validity of manufacturing / import authorisations should also be extended (if they are limited in time).
For new sites/facilities, a "distant assessment" conducted by an EU/EEA competent authority may be an option. A GMP certificate may then be "granted depending on the outcome of the assessment". However, "it should be indicated that the certificate has been granted on the basis of a distant assessment". Moreover, "an on-site inspection should be conducted when circumstances permit".
Question and answer 2.4 deals with the role and responsibilities for Qualified Persons (QP). In this context, remote batch certification and remote audits are discussed. And these may be possible under certain circumstances: "The remote batch certification is permissible under EU GMP rules, provided that the QP has access to all information necessary to enable them to certify the batch".
In the document it is acknowledged that some Member States may have additional or different requirements precluding remote certification but it is also stated that "considering the current restrictions of travelling linked to the COVID-19 pandemic, the remote certification should be acceptable in all EEA Member States."
Where on-site audits at API manufacturers are not possible, the "QP can rely on paper-based audits and also take into consideration the results of inspections from EEA authorities". The decisions should be based on a scientific basis and an appropriate risk assessment.