Good lab practice

The GLP principles cover all parts of a study, from considering how to do the work, through monitoring, to reporting and storing the data. GLP relates to studies - in pharmaceuticals, agrochemicals, veterinary drugs, industrial chemicals, cosmetics, food and feed additives, and biocides - in which risks to users, consumers and third parties (including the environment) are assessed and compliance to GLP is required. Adherence to GLP allows a regulatory body assessing any such study to have confidence in the validity and integrity of data obtained when, for example, making risk or safety assessments. If individual countries can confidently rely on data developed in other countries, duplicate testing can be avoided, thereby saving time and resources. Note, however, that GLP is not concerned with the scientific validity of the studies, this is the responsibility of the assessors to whom the studies are submitted. 

Teaching GLP 

This may sound like a rather dry topic to put across to undergraduates - it would be all too easy to get bogged down in a long series of acronyms and regulations. However, it is clearly important to address GLP at some stage in the curriculum. At the same time there is always pressure on the timetable and it is undesirable to devote too much time to 'non-chemistry' topics. 

Against this scenario we have worked with staff from the GLPMA of the MHRA to put together a teaching package that fits easily into the curriculum, is interesting to the students and hopefully provides students with the basic requirements of working in a regulated analytical environment, either as placement students or as full-time employees.  

We believe there are two ways to make GLP both accessible and interesting to students. First, we need to consider the sort of jobs that our students may be doing in a few years time. So part of the taught material focuses on the expectations of individuals in ensuring compliance to GLP. We introduce students to the roles of a study director and a principal investigator - both jobs that they may well be doing a few years after graduation but probably roles that they have not considered (see Box 2). These are responsible positions and it is useful to emphasise to the students that such responsibilities could soon be theirs.  

Since many graduates are likely to work as analysts at the start of their careers, we address the question - what is expected of an analyst who does part or all of a study? The key point, perhaps, is traceability of the work that the analyst has done and to emphasise that the analyst is responsible for recording raw data and for the quality of this data. Moreover, employers expect that they will be aware of GLP. Secondly, we ask the students to consider data which have been recorded as part of a study and, in particular, to look for potential flaws in the recording of these data.  

The most interesting way to approach a topic like this is by encouraging student involvement. Following an introductory lecture, we ask students to work in teams on workshop problems. Two problems that we have found to be particularly interesting are:  

• to consider a list of tasks in a study and decide on who should be responsible for those tasks; 
• to consider a set of calibration data and decide on whether the data would be compatible with GLP.  

These problems can also be used to teach transferable skills. Team working is important and we ask one member from each team to give a short presentation on their findings. This also serves to get students to question the way in which they address data. For example in one workshop problem, a Standard Operating Procedure (SOP) for calibrating a pipette requires the pipette to pass at 1 per cent accuracy. The analyst has done this by weighing 0.0050, 0.0250, 0.2000 and 1.0000 cm³ volumes of water but has used a four-figure balance for the work. Since you cannot measure 0.0050 cm³ with a 1 per cent accuracy on a four-figure balance, this test must fail. But is this a serious failure? The answer will depend on what the pipette is being used for in the studies. If it is crucial to measure 0.0050 cm³ volumes to this degree of accuracy then failure must be important, but if only larger volumes are being measured then the failure is not significant, but it does suggest that the SOP has been written without careful consideration and should have been revised. A useful exercise for the students is to take these ideas away and to consider, for example, the practical work that they are doing in other parts of their course. While they are not expected to work to GLP during undergraduate practicals, they should consider whether or not their work demonstrates good practice. They may like to write SOPs for apparatus that they use or devise a means to calibrate a spectrometer before recording a spectrum of an unknown sample.  

Students would also benefit from considering the following simple questions as they undertake practical work: 'Am I making this measurement to a sensible degree of accuracy?'; 'How should I best save and store the data that I have recorded?'; 'Will the balance still work if it is on a surface which clearly is not level?'. A basic knowledge of 

GLP helps them to consider such concepts and enhances their overall learning experience. 

Student feedback on this work is generally good. Comments have included: 'It was much more interesting than I thought it would be'; 'I have come across GLP at placement interviews so this was useful'. However, one student did say: 'People should be able to record their own data properly; there is no need for an authority like this'. Clearly an idealist, but as we do not live in such an ideal world GLP will remain an important part in the lives of analytical chemists. 

Dr Matthew Almond is a senior lecturer in the school of chemistry at the University of Reading, Whiteknights, Reading RG6 6AD and Dr Samantha Atkinson is a GLP inspector at the Medicines and Healthcare products Regulatory Agency (MHRA), 10-2 Market Towers, 1 Nine Elms Lane, London SW8 5NQ.

Further Reading

Bibliography 

• Good laboratory practice pocket book, MHRA. London: OECD, 1992. 

• Good laboratory practice, guidance on archiving, MHRA. London: OECD, 2006. 

• Good laboratory practice, OECD principles and guidance for compliance monitoring. London: OECD, 2006. 

• The good laboratory practice (codification, amendments  etc) regulations. London: The Stationery Office, 2004. 

• W. Y. Garner, M. S. Barge and J. P. Ussary (eds), Good laboratory practice, standards and applications for field and laboratory studies.  Oxford: OUP, 1992.