15/16 February 2022
"Innovation overcoming adversity". This is in the title of a publication by the European Directorate for the Quality of Medicines & HealthCare (EDQM) on the topic of real-time GMP remote inspections at active ingredient manufacturers (API) during the Covid-19 pandemic.
When the GMP requirements and regulations were written and introduced, no one had thought about a pandemic or anything like that. Then, in spring of 2020, many things changed. Also EDQM, which oversees both Good Manufacturing Practice (GMP) compliance and applications for Certificates of Suitability for European Pharmacopoeia (CEP) monographs at API manufacturing sites, had to curtail and adapt their inspection programme. For this purpose, the concept of "Real-Time Remote Inspections" (RTEMIS) was conceived and implemented.
"No distant GMP assessment can be as effective as an on-site inspection"; the EDQM was aware of this from the outset. But a possibility should be found that achieves a "higher degree of information on GMP compliance compared to the existing distant assessment procedure performed exclusively on the basis of documents". The aim was therefore to use live real-time video connections between the inspectors and the facilities to be inspected. In doing so, the following technical challenges, among others, had to be taken into account:
In September 2020, things got underway and the EDQM contacted production sites for a voluntary pilot phase that had already been inspected by the EDQM and had a good GMP compliance history.
It quickly became apparent that this type of remote inspection requires more thorough preparation than on-site inspections. Preparatory conference calls, connectivity tests and a redundancy strategy are also important.
The secure sharing of confidential documents in real time required some thought. For this, EDQM uses its own document sharing tool. Another important technical issue was what kind of mobile devices could be used to capture live images from potentially hazardous manufacturing areas. However, there are already "intrinsically safe" mobile phones for this purpose, which have been used for some time in other potentially explosive areas such as refineries.
The EDQM is satisfied with the results of the study. Even though the inspectors were not on site, a number of minor and major deficiencies was identified.
Based on the principles of quality risk management, remote inspections are to become part of the EDQM inspection programme. These come into play mainly in the case of travel restrictions or if the safety of the inspectors cannot be guaranteed. Real-time GMP remote inspections should also be possible with a corresponding GMP compliance history of the facility. However remote inspections will not be used to evaluate aseptic manufacturing processes.
Real-time remote inspections thus provide the EDQM with another option for assessing the GMP compliance of a site. At the same time, however, it is emphasised that these remote inspections cannot replace on-site inspections in terms of value and effectiveness.
Source: EDQM website