Below our life sciences sector group outline the latest guidance regarding the remote working and Qualified Person (QP) certification.
The MHRA has recognised that flexible, part-time or home working arrangements are mainstream for Qualified Person (QP) personnel in the pharmaceutical industry. Digital connections can allow us to continue to work effectively when we are away from the office. However, there is still a need to maintain market supply whilst the QP fulfils other duties or is restricted from travel.
Every organisation has its own way of working. Whatever the arrangements, these need to be specified within the pharmaceutical quality system and in any relevant written agreements with contracted parties. Inspectors will review how this is managed to ensure that control is maintained, and products and patients are protected.
MHRA notes in particular that:
We are all navigating uncharted waters as business and society faces up to the impact of COVID-19. We very much hope you and your loved ones remain in good health.
Please be assured that Fieldfisher is continuing to work with clients to navigate COVID-19 related issues and on business as usual needs. Do get in touch with us if you would like to chat anything through.
The MHRA has recognised that flexible, part-time or home working arrangements are mainstream for Qualified Person (QP) personnel in the pharmaceutical industry. Digital connections can allow us to continue to work effectively when we are away from the office. However, there is still a need to maintain market supply whilst the QP fulfils other duties or is restricted from travel.
Every organisation has its own way of working. Whatever the arrangements, these need to be specified within the pharmaceutical quality system and in any relevant written agreements with contracted parties. Inspectors will review how this is managed to ensure that control is maintained, and products and patients are protected.
MHRA notes in particular that:
- The QP must be able to demonstrate they are fulfilling their wider duties;
- Where remote QP certification is employed, it must be described and controlled within the pharmaceutical quality system;
- Accurate and up-to-date information must be available to support batch certification and release. See here.
We are all navigating uncharted waters as business and society faces up to the impact of COVID-19. We very much hope you and your loved ones remain in good health.
Please be assured that Fieldfisher is continuing to work with clients to navigate COVID-19 related issues and on business as usual needs. Do get in touch with us if you would like to chat anything through.