Preparing a global biotech company for inspection readiness

Always being inspection ready is integral to maintaining an effective Quality Management System (QMS), ensuring regulatory compliance, safeguarding the quality and safety of pharmaceutical products, and reducing risks and issues. Being consistently prepared for inspections fosters a culture of quality and allows companies to respond efficiently and confidently during both inspections and audits. This can subsequently reduce the number of inspection findings, and the time, effort, and cost required to address them, including avoiding fines and penalties. 

How can we enable a business to be better prepared for handling regulatory inspections? 

Recent audit findings for a global biotech company, coupled with the internal perception of inspection naivety among their clinical study teams, highlighted the need for improvement in their readiness and approach to inspections. The client challenged us to help them create an inspection strategy and approach, build their inspection capabilities, and increase the confidence of their study teams supporting programmes preparing for submission. 

How did we empower our client to improve their performance with inspections? 

Leveraging our experience and robust methodology for developing inspection readiness capabilities, we critically reviewed and assessed their study documentation and other relevant background information on known study risk areas. We also conducted exploratory interviews with key internal stakeholders to build a comprehensive picture to inform the inspection strategy and areas requiring focus during the inspection readiness activities. 

We conducted mock inspections with study team members to provide them with hands-on practice and experience of real-life inspection conditions. During the mock inspections, we gathered feedback and scored the interviewees on their technical knowledge and behavioural performance. We also developed inspection readiness plans and supporting preparatory materials, including key messages, topic storyboards, model response scripts, and FAQs. 

To further build confidence among the study team members, we ran a series of coaching and challenge sessions, which took the form of a hybrid of inspection conditions and workshop approaches. In total, we developed topic storyboards across 8-9 topics per study, as well as multiple challenge storyboards to provide consistency on what was done, by whom, when it was done, and what documentation exists to verify these activities.  

Improved inspection capability and confidence among study team members  

The improved capability and confidence of study team members were evident, with a feedback rating of 4.9 out of 5 when asked in a survey if they felt more prepared for inspections. 

To drive sustainable change and maintain the new knowledge and skills acquired after the project finished, we developed a playbook for preparing study teams for future inspections. This was handed over to the Quality team for use in business as usual and will complement the behavioural and mindset shift around inspections that was also embedded into the client team. 

Our client was extremely impressed with not only the outcomes of the engagement but also how we were able to build strong relationships with the study team members and work with them in a truly open and collaborative manner. We subsequently supported them with identifying and implementing portfolio-wide interventions to address systemic inspection readiness gaps.