Survey of qualified persons on remote certification
Social distancing posed an interesting question for the Qualified Person (QP) in the early days of the COVID-19 pandemic: Is it permissible, or practically possible, to certify batches for release while working from home? The European Qualified
Persons Association (EQPA) asked its members to share their knowledge and this article details what it found out.
In March 2020, the EQPA surveyed its members on the topic of batch certification performed by a QP whilst not physically present at the site of
the manufacturer, or “Remote QP Certification”. The topic was perceived as an area of non-harmonised national interpretations and the EQPA sought to better understand the differences across the European Union (EU)/European Economic Area and on how QPs positioned themselves in such a procedure.
The survey was launched shortly after the UK’s Medicines and Healthcare Product Regulatory Agency (MHRA) published views on the topic by way of its inspectorate blog in February 2020. At that time, the COVID-19 pandemic was rapidly spreading across Europe and public health bodies were promoting remote working where possible, in order to avoid unnecessary contact.
Survey and results The survey, responded to by more than 300 QPs, revealed an interesting pattern of approaches. As would be expected, the responses reflected the perceived expectations of their respective national authorities
and/or their understanding of national law. QPs acting in a generally acceptive environment for remote QP certification were much better equipped to answer
the questions posed in the survey than those who believed that their national law would not allow it. The EQPA believes that neither the EU Guidelines for
Good Manufacturing Practice (GMP) nor Directives 2001/8(2)3/EC require the
physical presence of the QP at the manufacturing site during certification. However, in several member states such physical presence is enforced, either
clearly through national law, or less clearly, by the interpretation of law by national authorities. An argument for the QP’s physical presence on site is that
the responsibilities of the QP can be met in full only through a high level of continuous interaction with manufacturing operations. Another known
argument is that QP certification, being an integral part of GMP regulation, can only be executed at the listed premises of the Manufacturing/ Import Authorisation Holder.
The EQPA was interested in whether rules might change in the face of a pandemic. It did not know how many QPs already had the freedom to exercise remote QP certification in their local environment. In this respect, the survey revealed an even split with almost 50% of QPs aware, at the start of the COVID-19 pandemic, that remote QP certification would not be an option on their territory.
This is an extract of an article by by Ulrich Kissel and David Cockburn from Industrial Pharmacy Issue 68 Subscribe to the IP