A spokesman for the UK-based International Register of Certified Auditors (IRCA), which launched its “Pharmaceutical Auditing Scheme” today, told in-Pharmatechnologist.com the idea is to establish a common training programme that – in contrast with other sectors - the drug industry lacks.
“To be an aerospace auditor, one has to attend a certain type of training course. However, this is not the case in the pharma sector,” he said, explaining that some auditors attend 9001 courses whereas others will have been trained in-house by the drug industry.
The spokesman explained that the IRCA training programme is modelled on the qualified person (QP) status, which is a professional status that must be held by individuals who release pharmaceuticals to the market in the European Union (EU).
“If you say ‘I’m a QP’ everyone knows what that means, and they know what you had to do to get there. But when someone says ‘I’m an auditor in the pharma industry’ – presently, all one could glean is that the other person claims to have conducted audits.”
The new scheme – which has already been completed by staff from AstraZeneca and the UK MHRA – is intended to be a “how to” guide for auditors.
The IRCA spokesman explained that it will provide the methods, techniques and skills necessary to carry out a professional audit.
“The course is not about learning standards, for example learning about ICH Q10. Students are expected to have a minimum ‘prior knowledge’ before attending the course. It is about understanding how to, and getting the skills to audit effectively.”
“The training is very participative and puts the students in scenarios where they get to practice their skills” he said adding that “IRCA is offering a benchmark for auditor competency. Passing the training course is just one competency indicator that needs to be satisfied before certification.
“Others include evaluation of work experience, evaluation of sector awareness and understanding, evaluation of audits completed – and then on an on-going basis submission of CPD, which I would strongly expect to see evidence of the auditor having kept up to date with changes in standards, but CPD covers a lot of other areas too.”