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.

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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.

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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).

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