Thursday 12 July 2012

Tips for Successful Method Transfer

Transferring an analytical method from one laboratory to another should be straightforward but unfortunately it is a process which is often problematic. Recognition of this has resulted in a new USP chapter <1224> Transfer of Analytical Procedures, and a proposal for inclusion in an update of the EU GMP regulations.

The most common source of problems is the analytical method itself. Either the method is not robust, or it may be that it has not been well written, leading to potential misinterpretation. Prevention of these issues involves a thorough review of the method by the sending laboratory prior to any transfer attempt. The robustness of the method should be assessed by investigating the critical method factors. If lack of robustness is identified, then either further method development or implementation of control strategies will be required. Running the method at the receiving laboratory is a good way to check that the method can be followed in a consistent fashion and that the staff and facilities at the receiving laboratory are satisfactory. This analysis should NOT be considered as part of the transfer, rather it is a pre-transfer activity. These measures should help to ensure that the prospects for a successful transfer are good.

Mourne Training Services is introducing a new training course to deal with the topic of transferring analytical methods for pharmaceuticals, which will be held at locations throughout Europe in 2012. In this one day course the different approaches to transfer are explored fully and case studies are used extensively to follow the process from review of the method prior to transfer, to creating a suitable protocol with relevant acceptance criteria, and evaluating the results generated to assess whether the transfer has been successful.

Visit the MTS website for information on where and when the course will be offered, the discounts available including our early booking rate, an online booking form and a detailed course description.

This course is ideal for anyone involved in the transfer of analytical methods. For example: Analytical chemists, laboratory managers/supervisors, quality control analysts/managers, quality assurance managers, and regulatory affairs managers.

Please note: Familiarity with the characteristics studied during analytical method validation is necessary for this course since these are used for method transfer. The MTS course, Validation of Analytical Methods for Pharmaceutical Analysis, is recommended.

Tuesday 10 July 2012

MTS Recommends... Product Focus: High-Purity Laboratory Water Systems

Product Focus: High-Purity Laboratory Water Systems
By: Angelo DePalma, Ph.D - Published: 9th July 2012, Lab Manager Magazine
The water used to prepare HPLC mobile phase is a common source of contamination problems. It is critical that a suitable water purification system is selected and maintained. This article provides an interesting overview of the available laboratory options.

Tuesday 3 July 2012

HPLC Training Courses in the UK

I will be delivering a series of HPLC training courses in the UK this October. The details are as follows:

How to Run HPLC Methods
London, 11th October 2012
Edinburgh, 17th October 2012

How to Troubleshoot HPLC
York, 10th October 2012
London, 12th October 2012
Warrington, 16th October 2012
Edinburgh, 18th October 2012

How to Develop HPLC Methods for Challenging Separations
Warrington, 15th October 2012

These courses are sponsored by Phenomenex. For more information: Tel 01625 501367 or email