Part 2

When the inspection is in progress, keep the inspection team addressed of any issues or problems as they arise.  If there are known issues with trials, explain the issue and the resolution taken to address that issue.  Explain and express the reasons for any issues that may be present within the TMFs.  Inspectors are aware that at times things can go wrong.  If there is a justifiable reason and explanation for the anomaly, providing that the subject safety or the data credibility is not affected there will be no significant outcome, but to have not told the inspection team of any anomalies will put up barriers.

Any documents that have been requested by the inspection team and are difficult to provide should be explained to the inspection team at the earliest opportunity.  Do not delay in providing relevant information.  Do not delay in providing prepared and cleaned documents.  If it is considered that there is an unnecessary delay and cleansing of requested documentation, further documents will be requested with a short turn round time expected to ensure the oversight of this area by the inspectors.  An informed inspection team is generally a happy inspector, whereas a team who are not adequately informed will have concerns and will try to understand the reasoning for the lack of information provision.

Be prepared to provide documents from trials other than those selected for the inspection.  Inspectors are aware that the selected trials will have been cleaned and prepared for the inspectors to review.  For those organisations that “appear” to have provided a “too clean” TMF, inspectors may ask for specified documents from other trials from the trial list provided as part of the dossier, or indeed a complete TMF for review.  In this instance there would not be time for cleaning of that trial file – another reason for constant inspection readiness.

In summary, this short blog is intended to give you some hints and tips for coping with and managing a regulatory inspection.  In reality however the only ones that can get you through the inspection hurdle are you, your organisation and the organisation’s belief in compliance and quality.  Be compliant, be regulatory aware and be flexible– these are verbs that will enable any organisation to “succeed” in an inspection.

The ADAMAS Corporate Brochure 2016

 

Brochure – Please download the ADAMAS brochure describing our QA services and contact details.

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Regulatory Environment

 

The development of medicines is the most regulated industry in the world, and compliance at each stage of the research and development process, as well as after licensing, is critical to ensuring high quality and safe medicines reach patients in a timely manner.

adamas-quality-assurance-services

 

ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.

 

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How to be a Clinical Auditor

 

‘So you want to be a Clinical Auditor?’, an article written by CEO Dr. Patricia Fitzgerald.

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Benchmarking Data

 

Please download our benchmarking data sheet, to see how these data compare with your own performance. To discuss a more detailed report, or analysis of a data subset, please get in touch.

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Is your QMS compliant?

 

Is your QMS compliant to the upcoming ICH E6 Addendum? Download our 5-point checklist

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ICH (E6) R2 Addendum - Step 4

 

Please enter your details to complete the download.

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