Thursday 28 February 2013

MTS Recommends... Getting it Write?

R.D. McDowall, LCGC Europe, Volume 25, Issue 11, pp. 630-639, 
Well written and easy to follow analytical procedures are critical in any lab but, as I often find during method transfer studies, the way a method is written can create confusion and errors. This article from Bob McDowall is a great read if you have the unenviable task of preparing procedures.

Tuesday 26 February 2013

How Does the Update to Chapter 6 of the EU GMP Guidelines Affect You? - Part 2

In a previous blog post I summarised the proposed changes relating to method transfer in the public consultation document for Chapter 6 of the EU GMP Guidelines. Although the inclusion of the section on method transfer is the biggest revision to chapter 6, there are number of other proposed updates. In this blog post I will take a look at some of these.
Since the reason given for the changes is: ‘Inclusion of a new section on Technical transfer of testing methods and other items such as out of specification results’, and I have already dealt with method transfer, I will start with out of specification results. Under the section heading ‘Documentation’, there is a new requirement for: ‘a procedure for the investigation of Out Of Specification and anomalous results and Out Of Trend results’ (6.7)
The expectation that a QC laboratory will have a procedure detailing how they will deal with OOS results is long standing and most labs will already have this in place. The wording makes it clear that this procedure also needs to detail investigation of anomalous results and OOT results. These are typically investigated in the same way as OOS results.
Also under the Documentation heading, the recommendation that records are kept in a manner permitting trend evaluation has been updated to ‘should be recorded in a manner permitting trend evaluation’ with the additional sentence, ‘Any out of trend or out of specification data should be addressed and subject to investigation.’ (6.9)
Sampling is another area which has updates. In 6.11, referring to sample taking, there is an additional requirement that it ‘should be done and recorded in accordance with approved procedures.’ Therefore, if the sampling operation is not currently documented each time, it will need to be in future. In 6.12 there is an extra sentence: ‘the sampling plan used should be appropriately justified.’ It may be that the plan was devised sometime in the past and reasons which were so apparent then are no longer so clear. The requirement to justify the plan ensures that it is scientifically sound.
Under the Testing heading the paragraph regarding method validation (6.15) has been extended to include the following ‘A laboratory that is using a testing method and which did not perform the original validation (e.g. the use of a compendial method), should verify the appropriateness of the testing method.’ So even if a method is taken from a pharmacopeia its use in a particular laboratory needs to be shown to be suitable for the purpose for which it is being used. This assessment may conclude that no actual experimental work needs to be performed but some type of documentation should support this finding.
A new paragraph (6.20) has been inserted which reflects the importance of reference standards, making it clear that ‘Reference standards should be certified, qualified and verified as suitable for its intended use.’
The shelf life of analytical solutions, etc. is addressed in section 6.22. The requirement to mark with the date of preparation has been extended to opening date. Additionally: ‘Their in-use shelf life should be established/documented and scientifically justified.
Finally, there are two new sections relating to the microbiological laboratory, these are:
6.21 Culture media should be prepared in accordance with the manufacturer’s requirements unless scientifically justified. The performance of all culture media should be verified prior to use.
6.25 Microbiological media and strains should be decontaminated and disposed of in a manner to prevent the cross-contamination and retention of residues. The in-use shelf life of microbiological media should be established, documented and scientifically justified.
In general, the emphasis of the updates is on scientific understanding and justification of the analytical methodology being used in the QC laboratory.

Monday 25 February 2013

Training Courses in London, April 2013: Analytical Method Validation & Transfer; Developing Stability Indicating HPLC Methods

In April, Mourne Training Services is offering 3 training courses in London. These are:

10th & 11th April 2013
Validation of Analytical Methods for Pharmaceutical Analysis

12th April 2013
Transfer of Analytical Methods for Pharmaceutical Analysis

15th & 16th April 2013
How to Develop Stability Indicating HPLC Methods

Click on the course titles above for more information about each course; including a course description, and a booking form containing costs and available discounts.

Submit the booking form or contact us by the 18th March to secure our early booking rate. The venue for the training is Jurys Inn Heathrow, convenient for travel by car or public transport.

If the dates don't suit you then take a look at our full course calendar for 2013. These courses are also available at our London location in November, and in Berlin (May, June & December) and Dublin (June).


Thursday 7 February 2013

New Course: How to Develop Stability Indicating HPLC Methods

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 measureable 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 year MTS is introducing a new 2-day course which will enable you to develop a suitable method. 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.
The course dates and locations are as follows:
15th & 16th April 2013: Jurys Inn Heathrow, London, UK
17th & 18th June 2013: Steigenberger Hotel Berlin , Germany
11th & 12th November 2013: Jurys Inn Heathrow, London, UK
9th & 10th December 2013: GLS Campus Hotel Berlin , Germany

Contact us if you have any questions about the course, the full costs are detailed on the booking form, click here.