HPLC method validation course

The high performance liquid chromatography (HPLC) technique has found wide application in determining the content of an active substance, and the level of impurities, in pharmaceutical products. While industry and regulatory laboratories utilise this technique on a daily basis, recent reviews and audit reports undertaken by the US Food and Drug Administration (FDA) highlight the importance of undertaking studies to establish that the procedure being used gives replicable and reliable results ie. that the method is validated for the intended purpose.

In line with this, analysts of the Chemistry Section of the TGA Laboratories Branch developed a hands-on course designed to familiarise participants with concepts and data that help to establish the suitability of an HPLC procedure for the analysis of a specific product.

Chemistry Section staff offered the course in response to a survey conducted within the pharmaceutical industry, which indicated a high level of interest in such a course. The three-day course combined tutorials on the principles of method validation with hands-on laboratory experience.

Each course was limited to 12 people, with participants divided into three teams of four for the laboratory based component. Both TGA staff and industry participants agreed that the course was a great success - it provided an opportunity to examine the elements of method validation and allowed the exchange of experience and expertise between industry and regulatory analysts.

We apologise to those applicants who were unable to be accommodated in the five courses conducted on this occasion. We plan to again offer the course, improved in line with participants' suggestions, during February/March 1996.