Good Laboratory Practice (GLP)
Good Laboratory Practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, monitored, recorded, archived and reported.
A non-clinical study is an experiment, or set of experiments, in which a test item is examined under laboratory conditions, or in the environment, to obtain data on its properties and/or safety, intended for submission to appropriate regulatory authorities.
What are the benefits of GLP?
- Credible analytical study data and reporting
- Promotion and acceptance of analytical study data internationally by registration authorities (removing the need for multiple inspections)
- Reduced technical barriers to trade though mutual acceptance of data
GLP services include:
- Preparation of a study plan/protocol to meet regulatory requirements
- Study Director/Principle Investigator to conduct the analytical phase of the trial in full compliance with the OECD Guidelines
- GLP compliant analytical services to support horticultural compound and veterinary drug registration applications internationally
- Development and validation of analytical procedures (can be GLP compliant)
- Ability to adopt methodology to suit the requirements of the customer
- A variety of analytical techniques including Enzyme-linked Immunosorbent Assay (Elisa), High Performance Liquid Chromatography, Gas Chromatography, Mass Spectrometry (GC-MS, LC-MSMS) and Microbiological Inhibition Assay.
- A detailed report in full compliance with the OECD requirements (retained for seven years)
We employ a dedicated GLP team and Supervisor to support the GLP services we provide. Our services are:
Traceable with accurately maintained documentation
Cost effective
Confidential
Easy to interpret with user-friendly reports
Our Wellington Laboratory holds MAF permits for the importation of restricted biological products of animal origin and plant based laboratory specimens.
|