GLP 5 Batch Analysis
EPP has recently been awarded GLP accreditation by the MHRA and as such, can now facilitate the entire screening, synthetic and reporting process required for GLP 5 batch analysis.
This award means that EPP can provide a 'one stop' service for our clients seeking to obtain GLP 5 batch analysis of their pesticide products. This approach saves our clients time and money, and helps to alleviate the problems and delays associated with using different contract laboratories for sequential parts of the process leading to GLP compliant 5 batch study reports.
The EPP approach to GLP 5 batch analysis is to follow a phased programme, progressing to the next stage depending on results obtained. Typically this approach would be:
* Perform general gas chromatographic or HPLC screens using flame ionisation and u.v. detection, respectively to indicate the number of significant impurities present above 0.1% w/w and to indicate borderline impurities (normally ≥ 0.06 %)
* Identify the significant impurities using GC-MS or LC-MS.
* Source, synthesise or isolate, and characterise the impurities in terms of chemical purity.
* Develop robust and precise assays for the quantification of impurities as well as the active substance.
* Provide a full GLP report summarising our findings, within an agreed template, for submission to the appropriate regulatory body.
At EPP our chemists have built up expertise in the separation, identification and quantification of impurities that may be present as a very small proportion of structurally similar or isomeric materials. Working closely with our clients, these experts can develop a rational and cost effective programme for identifying and synthesising the significant impurities for an active substance so that the necessary regulatory closure can be obtained, following the required assay procedures.