The impact of the Covid-19 pandemic on GxP supply chains and the lockdown measures mandated by the UK government and devolved bodies have resulted in restrictions in movement and the ability to visit supplier sites. This presents significant logistical difficulties in establishing supplier conformity to regulatory requirements by audit inspection and review. The MHRA has recognised this difficulty and have published guidance on their website to detail flexibilities which may be introduced at this particularly unique time to mitigate the impact of the lockdown restrictions specifically in the case of audits which cannot be physically performed by site visit.
The specific guidance in the news story published by the MHRA on their website “New arrangements for MHRA Good Practice (GxP) inspections due to coronavirus (COVID-19)” (on 20 March 2020 and subsequently updated) stated that:
“We are expecting organisations to maintain GxP compliance, and will support the industry and NHS to focus on service continuity by using alternative approaches for routine regulatory oversight, such as office-based assessment…”
The implementation of a remote audit, sometimes called a desk based audit can utilise video conferencing to conduct interviews with key personnel and remote review of documents and questionnaires which can provide information to base an assessment of compliance. Until further notice the MHRA intends use this approach to conduct essential regulatory inspections together with the intention to share information between regulatory bodies.
The practical upshot of this is support for risk-based assessment processes which have to be carried out remotely and online. At Tepnel Pharma Services the use of video meeting applications and other similar systems is a useful support to ensure information is communicated. The use of VPN to access secure network systems for document review and sample management permits remote assessments and approvals where required by secure electronic signature. Based on the guidance, a remote inspection of a supplier e.g. sub-contracted test laboratory will comprise the following elements.
- A review of the suppliers performance with complaints, non-conformances etc.
- Data review of relevant documentation, certificates, procedure, quality policy etc. Some of these may be available through the supplier website
- A questionnaire confirming GMP compliant elements are in place
- Video conferencing to interview key personnel, Quality and operational management, this may be limited with respect to site observation due to site security and confidentiality requirements.
This type of audit can be conducted either from an office or home location which is an advantage enabled by the use of the various online tools to manage communication and data review.
As the travel restrictions and lockdown measures are set to run for some weeks the adoption of these virtual and online inspection strategies is a useful means to continue assurance of the quality of the supply chain.
A PIC/S guide is available (PI 048-1 June2018) which discusses the conduct of remote regulatory inspections and provides a useful pointer to regulatory thinking in this area.
A McCallum, Senior Quality Manager, Tepnel Pharma Services Limited
9th April 2020