What can the industry do to facilitate remote and distant assessments? Are distant assessments ‘here for now’ or ‘here forever’? Will the future be a ‘Hybrid model’? Will onsite inspections be prioritized once it is safe to travel and what framework will be applied to inspections?
These questions and more will be answered during the 2021 ISPE Global Pharmaceutical Regulatory Summit on 28 April. Watch this video to hear from Thomas Hartman, President & CEO, ISPE, as he highlights featured global health authorities and the in-depth, interactive discussions you can't join anywhere else.
The management and assessments of inspections of manufacturing facilities or other sites relevant for medicinal products have become increasingly difficult. In March 2020, the MHRA announced a risk-based prioritization of Good Practice inspections due to the COVID-19 outbreak. Followed by the EMA, who developed, in October 2020, an EU-wide procedure on guidance related to GMP/GDP and PMF distant assessments. In addition, the WHO’s Expert Committee on Specifications for Pharmaceutical Preparations has Annex 9 in place: Guidance on good practices for desk assessment of compliance with good manufacturing practices, good laboratory practices, and good clinical practices for medical products regulatory decisions. Other organizations such as the FDA, PIC/S ICMRA are in the process of publishing guidance as well. These guidelines/measures should ease the impact of disruptions caused by COVID-19. These measures provide guidance for stakeholders on adaptations to the regulatory framework to address COVID-19 challenges.
The concerns connected to distant assessments are multiple in terms of both the means required and the possible approaches.
The resulting time and cost savings suggest that distant assessments may remain popular in the future; however, it is necessary to be aware of the limitations to ensure efficiency and compliance.
These are all issues that we will explore globally during this event with regulators, auditors, remote auditors, and inspectors.