Due to the current Sars-CoV-2 outbreak, more and more people started working from home; this includes Qualified Persons (QPs). But what do the regulators say when it comes to batch certification?
A recent publication of MHRA in their blog is addressing an often discussed topic whether a Qualified Person (QP) is allowed to perform batch certification from home (“remote QP certification”). In the UK, there is no regulatory requirement for the QP to be physically present at the site of manufacture or importation to perform the certification process for an individual batch and MHRA concludes that a system can be set up, which would allow remote certification. Prerequisites are:
- The QP must be able to demonstrate they are fulfilling their wider duties (this however includes regular presence at the site and an active role in quality management).
- Where remote QP certification is employed, it must be described and controlled within the pharmaceutical quality system (SOPs and technical agreement if company employs a contract QP).
- Accurate and up-to-date information and relevant batch-specific information must be available to support batch certification and release.
This position is of course made on a national perspective. Other EU Member States come to different conclusions and it seems some do not even allow remote QP certification.
A communication from the Irish HPRA on the same topic lists the conditions under which remote QP certification is found acceptable. In Ireland, there is a legislative requirement for the QP to be present at the authorised site when performing batch certification. The relevant legislation permits use of alternative premises, from time to time, if approved in writing by the HPRA. Such an approval would be conditional and the following arrangements and confirmation of these aspects should be provided with the proposal:
- The certifying QP would need to have access to all information necessary to enable them to perform the batch certification steps;
- The address where batch certification takes place will be recorded as part of the certification documentation;
- Any batches certified under this process would be documented within the non-conformance / deviation management system if the relevant SOPs have not been updated to reflect this change;
- The recording of the batch certification in the register (or equivalent document) would be contemporaneous.
What is the EU Directive saying?
DIR 2001/83 (Article 48) states that “Member States shall take all appropriate measures to ensure that the holder of the manufacturing authorization has permanently and continuously at his disposal the services of at least one qualified person […]”
It could now be at least discussed whether “at his disposal” could be mean that work from home and remote certification is an option as long as all other provisions are met. The EU Directives and Annex 16 do not specify how much time a QP should spend at the manufacturing site; neither do they discuss remote batch certification by the QPs. The interpretation of the requirements by national inspectorates and their respective expectations are not harmonized across the European Union/EEA/UK.
Conclusion: at present, a harmonized approach at EU-level would be needed. An EU Executive Steering Group on shortages of medicines caused by major events has been set up and they might be looking at all issues including QP certification. Hopefully there will be an EU-wide action plan and agreed position on this particular topic. The European QP Association has also taken up this matter and will consult its members on it. We will also publish the results in this newsletter.