Part 1

Firstly, it is important to understand that inspections should not be considered as either “successful” or “unsuccessful”. They take place based on the relevant legislative requirements, and findings that arise are a result of inadequacies in the quality management system (QMS) in place for the management of clinical trials of Investigational medicinal products (CTIMPs). Consequently, organisations do not pass or fail inspections. The regulatory outcome of an inspection is the report which will document those non-compliances which the inspectors were able to observe during the inspection. The organisation has to address those findings in order to improve compliance with the legislation and regulations relating to CTIMPs and therefore the organisational outcome of any inspection will be an increased compliance with the relevant regulations and guidelines and improved quality. Addressing the findings in the report does not only mean correcting the observed finding documented within the report, but should also involve a review of the QMS to prevent the same occurrence happening in any future CTIMP. Furthermore, one area which is often overlooked is the need not only to correct the reported finding in that study, but to address the possibility of the same finding for all ongoing trials where it is likely to have occurred or be occurring. To correct a single trial as a result of an inspection report without looking for the same finding in all other relevant trials indicates an improper view of the systems by any quality team.

An important factor for any inspection is to be “inspection ready”, at all times, but this term is overly and improperly used. It should not take a notice of inspection to cause an organisation to review its QMS. This action indicates that the organisation has not been working effectively in real time and is working reactively rather than proactively. In addition, it is not only the QMS that should be always inspection ready. As well as the QMS, it is important that trial master files (TMFs) are “inspection ready” but not just for an inspection – at all times. Any TMFs which have been prepared for specifically for an inspection indicates an inadequacy within the TMFs, and that prior to the inspection the TMFs would be of poor quality and not compliant with either the regulations or the organisation’s QMS. It is important to note that agencies are able to perform unannounced inspections and therefore the trial and the trial data should at all times be compliant with the necessary regulations.

All staff involved in CTIMPs need to be prepared for any inspection. However it is important that staff are not be overly trained for the inspection process. This can make them overly stressed and nervous. Remember an inspection is not a personal examination of staff, but is an inspection of the systems of that organisation relating to CTIMPs. All staff should be aware of the regulatory requirements required for their role within the trial. Staff should also know the processes within the organisation and the compliance of these with the regulations. With this background knowledge there should be no reason for undue nervousness. Staff should be proud in the job that they have performed, be proud of the whole team involved and be assured that in general the trial was compliant with the required regulations.

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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