IRCA Registered Pharmaceutical Auditor/Lead Auditor

IRCA Pharmaceutical Auditor/Lead Auditor

This unique 5-day course is highly recommended for anyone concerned with the quality management systems operated by suppliers of starting materials to the pharmaceutical industry. It has been developed and run over many years in the UK, Europe and the Far East.

The course is based on GMP as it relates to starting materials and specified in the PS 9000 series of standards. PS 9000 applies to contact and secondary packaging and printed components such as labels and patient information leaflets; PS 9100 specifies graded levels of GMP for inactive materials dependent upon their use (e.g. liquids for eye drops would have the same level as the GMP used by the pharmaceutical manufacturer, whilst oils for external ointments would have a lower level of GMP). These standards have been developed over more than 15 years and are published in the UK by the Pharmaceutical Quality Group (PQG) of the CQI. This is made up of quality executives from most of the major pharmaceutical companies and their suppliers. There is an associated certification scheme for company registration. The UK medicines regulator endorses the PS 9000 series and some of its inspectors have attended the course.