Laboratory accreditation and certification

ISO 17025 accreditation (IANZ)

The Pharmaceutical Programme is ISO 17025 accredited by IANZ and is regularly audited to ensure on-going compliance against the international standard.

GMP certification (Medsafe)

The Pharmaceutical programme meets the international requirements for Good Manufacturing Practice (GMP) and is regularly audited by the Ministry of Health (Medsafe) to ensure compliance against the New Zealand Code of Good Manufacturing Practice.

Pharmacopoeial requirements (BP, EP, USP)

Many of the test methods performed by the Pharmaceutical Programme comply with the requirements of one or more of the major international pharmacopeia – normally the British Pharmacopeia (BP), the European Pharmacopoeia (EP) or the United States Pharmacopeia (USP).

Note: the pharmacopeia from each of these jurisdictions detail lists of drugs, their formulas, methods for making medicinal preparations, requirements and tests for their strength and purity, and other related information (contained in ‘monographs’).

Internal quality management system (QMS)

The Pharmaceutical Programme has a focus on the delivery of quality testing services, and achieves this by maintaining our quality management system (QMS) to an extremely high level. The maintenance and effectiveness of our QMS forms a significant part of audits of our facilities by IANZ (for ISO179025 accreditation), Ministry of Health for GMP, and regular client audits.