Recently, the MHRA published a detailed blog post on GCP Inspections: Expectations and the dos and don’ts for hosting. This post includes a lot of excellent information not previously available in any published form. It covers notification, planning, conduct, documentation, system access, findings, and much more. The following points are particularly interesting, especially for those who have not actually experienced an MHRA inspection.
You will receive an email notifying you of an upcoming GCP inspection and requesting a dossier. In your response, ensure accuracy and check you have the trial ID and EudraCT number listed (even if you are a contract organization). Don’t start pestering the Lead Inspector about trial selection at this point.
An inspection plan will be provided in advance of the inspection. The plan will detail the trial selection and may also indicate particular systems we will be concentrating on. Understand this will be subject to change.
You should appoint an Inspection Host and ensure the Host is available via telephone and email to manage any further requests and queries throughout the inspection. The Inspection Host can be key to a smooth inspection; the host needs to be sufficiently senior, to have a thorough understanding of the organisation and the processes (to ensure they know where to get the answer to any questions) and should be an excellent organiser and communicator.
However, don’t allocate only senior management to inspection interviews who are not involved in the day to day processes and therefore are not familiar with the detail of the procedures and associated documentation, as often the detailed questions as to how it happened/worked during the trial cannot then be answered. This then leads to follow-up sessions and questions being needed.
Accessing Electronic Systems
Direct access will be required to all systems that make up your TMF and potentially any key clinical trial support systems. For example, if all of your SOPs, procedural documents and training records are held in a QMS eSystem, access will be required. If MHRA is looking at Computerised System Validation (CSV) we’ll also need access to systems that manage that system, for example, helpdesk systems. Take practical measures to aid electronic system access, such as providing links on desktop and short crib sheets, ensuring lock-out times are reasonable, minimizing need for numerous passwords where possible, etc.
Findings Communication and Timelines
Any findings and concerns will be raised with the organization as they are found as this should ensure the organization has the opportunity to provide any further clarifications during the inspection and the organization understands the issue and has the opportunity to start to think about impact and CAPA. All findings will then be collated by the Lead Inspector and summarised at the closing meeting.
If critical findings have been found an expedited letter will be provided and responses to the critical issues required in advance of the full report. The full inspection report will be provided by the Lead Inspector within approximately 25 working days of the last date of the inspection (this could be the last outstanding paperwork to be submitted or the end of the last investigator site inspection). If there are any delays in providing the report the Lead inspector will let the organisation know. The organisation then has 25 working days to provide a written response and CAPA to all findings.
Communication is key not just with the Lead Inspector, please copy in the full inspection team on any emails. This enables the full team to keep up to date with the inspection and if the Lead Inspector is not available one of the Assisting Inspectors can help with any urgent queries.
The full blog post contains much more useful detail. Finally, it wraps up by reminding you that MHRA GCP Inspectors like to drink lots of tea!
Kathie is an expert in content management for the pharmaceutical industry, with over 20 years of experience implementing enterprise-level, validated solutions for major life sciences companies in the US, Europe, Japan and Israel. In her prior positions, Kathie was responsible for the design and development of a number of document management products. She is the author of many white papers and blog postings and is a regular presenter at industry conferences. Kathie is also a member of the DIA TMF Reference Model steering committee.