Friday, 25 April 2014

EU GMP Chapter 6 Updated - Effective from 1st October 2014

The revision of EU GMP Chapter 6 on Quality Control has now been finalised and will be effective from 1st October 2014. The reasons for change on the new document are summarised as: "Inclusion of a new section on Technical transfer of testing methods and other items such as out of specification results."

The finalised document is mostly similar (a few of the proposed changes have not made it in) to the proposed draft that I reviewed in two blog posts last year.

The new section on method transfer is summarised in the first blog:
How does the Update to Chapter 6 of the EU GMP Guidelines Affect Your Lab?

The other updates in Chapter 6 are covered in this follow-up blog post:
How Does the Update to Chapter 6 of the EU GMP Guidelines Affect You? - Part 2

Ensure that you are up to date with the method transfer expectations of EMA, FDA and USP by attending the MTS training course, 'Transfer of Analytical Methods for Pharmaceutical Analysis'. Next opportunity is on the 2nd October 2015 in London. Check out our Course List for details of other dates and locations, and other courses, or contact us for more information.

 

Thursday, 17 April 2014

The Nature of 'Error' in Analytical Testing

It is important for anyone working in an analytical laboratory to have a through understanding of potential sources of error, and how the implementation of an effective laboratory quality system works to both minimise the effects of inherent sources of error and eliminate human error.

The meaning of 'Error' is very particular when applied to analytical testing. It is defined as the difference between an individual value and the true result and is regarded as having two components, namely, a random component and a systematic component. Random sources of error cause replicate measurements to fluctuate randomly around the mean, e.g., variability of HPLC injections. Systematic sources of error cause the result to be higher or lower than the true value, e.g., the assigned purity of a reference standard. Both types are inherent in the analytical method and are controlled by the elements in a typical quality system, such as calibration of instruments and equipment, and management of reference standards. They may also be introduced by the analyst, as human error, therefore suitable training in both correct procedures and the quality system is essential.

Mourne Training Services have now introduced a new training course to address this topic. It is day 2 of our 3 day course, 'Laboratory Data Integrity', and may be attended as a single day or as part of the full course.  

Brief course description:
Applying Data Integrity in the Laboratory; Minimising Analytical Error
This course deals with the effects of analytical errors on laboratory data integrity. This involves building an understanding of the nature and sources of analytical errors so that their effects can be minimised during testing, leading to high standards of data integrity and reduced numbers of OOS/OOE results due to laboratory errors.

It is aimed at everyone working in an analytical laboratory, being both a perfect introduction for new starters and a useful refresher for more experienced analysts. Full details are available on the MTS website and if you would like us to deliver this course in your laboratory just Contact us for more information.

 

Tuesday, 15 April 2014

Help on: Do I need to revalidate my method if I change the HPLC column?

MTS Helpdesk - Send us your questions about pharmaceutical analysis
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 would like to have a 'back-up' column for my HPLC method so that I am not reliant on one supplier, but how can I choose one that will be suitable and do I need to validate the method fully on the replacement column?"

Answer:
"My preference is to develop a new HPLC method on a popular column from a reliable supplier. This gives me confidence that the manufacturing process is well established and the batch to batch variability of the columns is likely to be low. Although a back-up column may be reassuring, it is not really necessary at this stage. I normally write the phrase 'or equivalent' after the details of the column in the method, which will allow investigation of an equivalent column in the future should it be necessary.

In this scenario it is important that if a back-up column is selected at a later date, it does actually produce the same chromatography, and is therefore equivalent. I would suggest that the USP database (http://www.usp.org/app/USPNF/columnsDB.html) would be a good resource to help choose a column which is likely to be equivalent. Scroll down to the 'PQRI database' and see if your current column is in the database. If so, you will be able to identify some potential candidates.

If you find that the retention times, and more importantly band spacing (or relative retention times) are much the same on the new column when compared to the original column, then an equivalency study should be sufficient to show that the columns are equivalent. This may be a simple repeatability study on each column combined with the system suitability requirements being met. The precedent for not embarking on a full validation study for the new column is that this is the approach used by the pharmacopeia.

If a back-up column is chosen which does not give the same chromatography as the original column then it is more likely that a full validation on the alternative column will be required since the methods are not equivalent. This is probably best judged on a case by case basis."

http://www.mournetrainingservices.co.uk/course_list.htmlIf you would like more advice on problems relating to HPLC or method validation, then why not come along to an MTS training course? Visit our Course List to browse our upcoming dates and locations. Or contact us for more information.

 

Friday, 4 April 2014

Training Courses on Method Validation and Transfer in London - May 2014

Training Courses on Method Validation and Transfer in London - May 2014
The next event in the MTS open enrolment training course schedule for 2014 will be held in London on the 28th to 30th May.

The courses on offer are:
Validation of Analytical Methods for Pharmaceutical Analysis, 28th & 29th May - early booking rate is £850 + VAT
Transfer of Analytical Methods for Pharmaceutical Analysis, 30th May - early booking rate is £495 + VAT

Check out the Course List page on the MTS website for more information on these training courses, including detailed course descriptions. More details about costs and available discounts for multiple course bookings and groups can be found on the booking forms (also accessed from the course list page).