Testing to the Good Laboratory Practice (GLP) standard

Good Laboratory Practice (GLP) is a testing quality standard governed by OECD guidelines. GLP testing is required by industries that need to submit supporting documents to regulating bodies to gain registration for their newly developed products. Examples are agricultural chemical companies that develop pesticides for the horticulture market and animal health companies that develop veterinary medicines.

In order to ensure full compliance to GLP, and to ensure that client's requirements are met, Hill Laboratories need certain information from the client at the outset of the study, we provide an Application Form for this purpose. This form, when completed, will provide all the information needed by the laboratory so we can provide the final report on time and ensure it contains all the data required in the requested format.
Completing the Application Form also provides all the information needed to prepare a quote for the work. It allows the laboratory to schedule the work to fit in with milestone dates. Providing the form ahead of time ensures that laboratory staff and instrumental resources are booked in. In busy periods it can be difficult to fit studies in on short notice.

Some of the key information on the form that helps the laboratory in its planning and scheduling is as follows:

1) Will the field phase of the study be conducted under GLP?

If this is the case then the field Study Director prepares the Study Plan and Study Report and appends the Analytical Plan and Analytical Report. The analytical documentation must therefore align with the Study Director's requirements. If the field phase is non-GLP the Study Director is from the analytical facility. It is critical to have this differentiation determined at the beginning of planning.

2) What are the timeline details?

The key dates for the laboratory are:

• Date samples to be delivered to the laboratory
• Date final report required (eg to meet registration submission deadlines)

The analytical work, writing of the report and auditing processes must all be completed in this timeframe. Early notice of these dates allows the work to be scheduled to ensure time deadlines are met.

3) What analytes are to be tested and what methods are to be used?

All compounds to be tested need to be identified at an early stage. Often there are metabolites or marker residues to be included in the testing and standards for these compounds need to be sourced. Early clarification as to whether specific sponsor methods are to be used also assists the early planning process. The method to be used also affects the pricing structure as sponsor methods require a validation process before use.

4) How do you want the results reported?

Reporting of results is typically in mg/kg and corrected for recovery. If an alternative format is required the laboratory can provide this but notice needs to be given so that this is included in the Study Plan.

The key to a successful GLP partnership is communication - sharing all the relevant information at an early stage of the process. With Good laboratory Practice, good planning leads to good outcomes.

GLP Application Form

Contact Us Today

• Barry Axon
• Colin Ogle
• Chris Berkers

Contact us today on 07 858 2000 (North Island) or 03 377 7176 (South Island) to find out more about GLP testing