MTS Recommends... Life Cycle Risk Assessment of HPLC Instruments

Life Cycle Risk Assessment of HPLC Instruments

By Paul Smith, R.D. McDowall
LCGC Europe
Volume 28 Number 2
Pages 110-117
Feb 01, 2015

"What does risk assessment in the context of the life cycle of a high performance liquid chromatography (HPLC) instrument really mean? This instalment of "Questions of Quality" will look at problems with an operational liquid chromatograph to see if they can be picked up in the performance qualification (PQ) or prevented in the operational qualification (OQ). The relationship between PQ and OQ and the design qualification (DQ) phases of the life cycle are also explored."

Course: How to Develop Stability Indicating HPLC Methods

Summary:
Pharmaceuticals need to be assessed for stability to support the assigned shelf life. Therefore, when analysing stability samples obtained from these studies analytical methods are required which are stability indicating, i.e. there is a measurable response which correlates with degradation, if present. HPLC is a popular technique for monitoring the decrease in drug and corresponding increase in degradation products due to its separating abilities. However, the HPLC method must be developed carefully to ensure that degradation products are both separated and detected appropriately.

This two day training course is designed to provide a thorough understanding of how to develop HPLC methods specifically designed for stability indicating analysis of pharmaceuticals. The course will describe strategies for performing forced degradation studies and selecting optimal HPLC method parameters to ensure that all relevant degradation products are separated.
Click here for Agenda & Detailed Course Description (printer friendly)

Suitable for:
This course is ideal for those who have some experience of using HPLC and need to ensure that they are stability indicating.

Included:
Comprehensive course handouts; Certificate of Attendance; access to training resources via e-MTS; optional post training assessment (leading to Certificate of Training); and post training support. Lunch and refreshments are included for open enrolment training courses.

Availability:

Open Enrolment Training
Click here for Costs & Online Booking Form.

London, UK - 19th & 20th May 2015
Venue: Hilton Garden Inn, London Heathrow Airport
For early bird savings, book on this course before 21st April.

Dublin, Ireland - 21st & 22nd September 2015
Venue: Metro Hotel Dublin Airport
For early bird savings, book on this course before 25th August.

Berlin, Germany - 26th & 27th November 2015
Venue: GLS Campus Berlin
For early bird savings, book on this course before 25th August.

On-site Training
The course may be delivered at your site; this option includes customisation to meet your specific requirements and may include ‘hands-on’ sessions using the instruments in your labs.
Contact us for a quotation. Visit the Course List page on our website for full details of all our available training courses in 2015.

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Help on: The Use of 'Test Injections' in Chromatography

MTS HELPDESK
Do you have any problems relating to analytical chemistry for pharmaceuticals or training? Send your questions to the MTS helpdesk using our contact form.

Question:
"I have noticed that in recently published FDA warning letters, the use of 'test injections' comes up as an adverse observation quite regularly. Does this mean that I shouldn't use test injections prior to HPLC analysis? I usually perform one or more injections before system suitability to make sure that the chromatography is as expected, since sometimes the first injection is not the same as those injected afterwards."

Answer:
"Most chromatographers would agree that it is quite legitimate to perform an injection to check if the system is ready to use and that for some methods the test injection may be different to subsequent injections. Thus 'test injections' are a common feature in many analytical laboratories.

Unfortunately, the practice was seemingly willfully misinterpreted in some laboratories to provide an opportunity to falsify data and this has resulted in intense scrutiny of the use of 'test injections' during regulatory inspections.

My main piece of advice is that it should not be necessary to use the sample solution (i.e. the test solution prepared from the material that you will generate a reportable result for) for a test injection and it is wise to avoid this. In my opinion, a test solution which was prepared for use as a standard would be appropriate as a test injection but even this approach has come under suspicion due to observed manipulation of the data from sequences of standard injections.

Therefore, an explicit procedure which details exactly how test injections will be used and also how the results will be recorded is advisable. Storing test injection raw data (e.g. chromatograms) separately to the data for the analysis (i.e. in a different file electronically) is often seen as suspicious. Obviously, knowledge of the contents of this SOP is essential for all analysts using HPLC. This information could be included in a generic HPLC SOP which details other important information, e.g., use of blank injections, system suitability, injection sequence setup, integration policy, etc.

Since the use of a test injection is usually method specific it would also be advantageous if relevant information was included in the particular analytical method."

Guidance on this topic is available from the FDA in their draft guidance on data integrity, click here.

The topic of 'test injections' is an important data integrity issue and is thoroughly examined in the MTS course, Laboratory Data Integrity. Visit the MTS website for more information.


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2015 Training Course Schedule from MTS

Our 2015 schedule is now available. You can choose from topics such as analytical method validation, method transfer and/or method development in London, Dublin or Berlin. Book early for the discounted rate!

Visit the Course List page on our website for full details.

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iLearn, the e-Learning HPLC Course from MTS

Summary:
Introduces the information required to understand the technique of HPLC and how it is applied to pharmaceuticals. Includes a discussion of: the different types of HPLC; types of stationary phases used to pack HPLC columns; the solvents and additives used in HPLC mobile phases; and the instrumentation used for HPLC analysis.

Suitable for:
This HPLC training course is aimed at beginners, but will also be useful for those with limited experience who wish to gain a better understanding of the technique.

Availability:
This is an on demand open enrolment training course and is delivered online by e-Learning through e-MTS using a combination of videos, exercises and an assessment. The content is equivalent to 1 full day of training. All the training materials are available for 1 month and the learner decides when to watch the videos and complete the exercises and assessment.

Cost:
£125 + VAT per person. Includes: access to all the training materials through e-MTS; tutor feedback on exercises via email; a certificate of training on completion of the assessment; and a copy of the MTS training book, An Introduction to HPLC for Pharmaceutical Analysis.
More Information on this e-Learning HPLC Course (including booking form)


Visit the Course List page on our website for full details of all our available training courses.

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Pharmaceutical Analysis Training Delivered at your site by Mourne Training Services

On-site training courses are ideal when training is required for a group of learners. Significant savings may be made when compared to open enrolment training. Additionally, there are no expenses associated with travel or accommodation.Courses can be customised to include hands-on sessions using the laboratory equipment that the learners will operate after the training. All that is needed is a quiet room of a size suitable for the number of learners being trained, and access to any appropriate laboratory equipment.

The courses detailed on the MTS Course List are all available as on-site training. This includes:

Validation and Transfer of Methods for Pharmaceutical Analysis
How to Develop Stability Indicating HPLC Methods
How to Run HPLC Methods
How to Troubleshoot HPLC
How to Develop HPLC Methods - Part 1
How to Develop HPLC Methods - Part 2 

These may be customised and combined as required to provide a bespoke training programme which is both relevant and effective. We also offer a range of consultancy services related to training.

Attendees on all MTS courses are encouraged to bring along examples of problems, challenges etc. which may be relevant for discussion during the training. The MTS trainer is happy to enter into a confidentiality agreement should this be required. Consideration of real examples which have relevance to the learners will aid understanding and retention of information.

Contact us to discuss your in house training requirements and we will prepare a competitive quotation based on your specific needs.


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