Validation of Clinical Trials Facilities – Getting it Right from the Start

Tabriz Consulting’s principal pharmaceutical quality consultant, Dr Afshin Hosseiny, has recently returned from a visit to a US-based manufacturer of microbicide delivery systems. As part of preparation for phase three clinical trials manufacture, our client needs to validate their facilities and equipment in accordance with EU GMP expectations as laid down in ICH Q8.

In accordance with our policy on the tailoring of training solutions to customer needs (see our website for details of our ‘Insight’ training programmes), Dr Hosseiny worked with the client’s management team to understand their business. Together they developed a cost-effective validation training programme that targeted their specific requirements and was delivered at their own premises.

The programme included:

  • Regulatory requirements on qualification/validation
  • Risk assessment: how to use risk assessment to conduct meaningful validation
  • Impact assessment: classification of systems, device criticality, functionality assessment, determining qualification requirements
  • Qualification: validation master plan, installation qualification, operational qualification, process qualification, test protocol design, requalification, change control
  • Cleaning validation: protocol, risk assessment, sampling, limits

Feedback from the trainees was extremely positive and we have been asked to provide further training and to support a programme of supplier audits.

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