Good Laboratory Practice (GLP)
The Organisation for Economic Co-operation and Development (OECD) Principles of Good Laboratory Practice (GLP) are an internationally accepted set of principles concerned with the planning, performance, monitoring, recording, reporting and archiving of non-clinical health and environmental safety studies, required by regulations* for the purpose of registering pharmaceuticals, pesticides, food and feed additives and veterinary drugs and similar products.
The Wellington Laboratory has been registered as a GLP accredited laboratory through the International Accreditation New Zealand (IANZ) GLP Compliance Monitoring Programme since 1996.
GLP services at AsureQuality include:
- Dedicated full time GLP team, consisting of experienced analytical phase Study Directors / Principal Investigators, analysts and technicians.
- Access to in-house veterinary medicine and agrichemical methods, or can transfer customer methods into the laboratory
- Method development and validation capabilities
- Access to a range of analytical techniques, including High Performance Liquid Chromatography (HPLC), Gas Chromatography, and Mass Spectrometry (GC-MS, LC-MSMS)
- Tailor written study plans and reports to comply with the OECD guidelines, and customer and regulatory requirements
- QA auditing of study plans/protocols, raw data and report (report includes a signed compliance statement)
- Knowledge and understanding of regulatory affairs ensures that data is suitable for submission to worldwide regulatory authorities (ACVM, APVMA, FDA etc)
- All test data, reports and information treated as confidential between the customer and AsureQuality
- Secure archive facilities on site for retention of records (routinely 7 years)
Scope of registration
20.01 Physical - chemical testing
(c) Active ingredient assay in agricultural chemical and veterinary drug formulation
20.08 Analytical and clinical chemistry testing
(a) Analysis of agricultural chemical and veterinary drug residues in biological tissues and fluids and agricultural samples
GLP accreditation certificate
Our Wellington Laboratory is a MAF accredited transitional facility so can accept overseas samples.
| * Why do world wide Regulatory Authorities such as The New Zealand Food Safety Authority (NZFSA), Agricultural Compounds and Veterinary Medicines (ACVM) Group, and the Australian Pesticides and Veterinary Medicines Authority (APVMA) require GLP compliance for residue studies? |
|
GLP compliant studies require true and accurate record keeping to enable full traceability of all results, and as such are subject to in-process, raw data and final report audits by our Quality Assurance (QA) Department. Submitting a GLP compliant study helps assure regulatory authorities that the data they are presented with is a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.
|
© 2012 AsureQuality - Page viewed on 19/05/2012 at 10:20AM
