Compliance

Revised: 25 July 2012

GMP Certified Contract Testing Laboratories

Company Name Postal Address Scope Summary1
AsureQuality Ltd PO Box 41
Shortland Street
Auckland 1140
  1. The chemical and physical laboratory assessment, microbial limit testing and preservative efficacy testing of raw materials, including purified water, in-process and finished products for:
    • Nutritional or ‘nutraceutical’ (vitamin, mineral & herbal) products where minor therapeutic claims are made, including products intended for the Australian market where they are termed ‘listable’
    • Medicines including those intended for the Australian market where they are termed registered medicines.
  2. The analytical and instrumental techniques as applied to 1:
    • Wet Chemistry
    • Thin Layer Chromatography (TLC)
    • UV/Visible Spectrometry
    • Gas Chromatography (GC)
    • High Performance Liquid Chromatography (HPLC)
    • Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES)
    • Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
    All testing performed according to pharmacopoeial requirements, client-supplied methods, in-house methods or methods specified in published standards, as required by the appropriate Regulatory Authority.
Biomed Ltd PO Box 44069
Point Chevalier
Auckland 1246
  1. The microbiological laboratory assessment of medicines, medical devices and raw materials (including purified water), in-process samples and finished products.
  2. The test methodologies as applied to 1:
    • Microbial enumeration testing.
    • Sterility testing.
    • Endotoxin testing.
    All testing is performed according to pharmacopoeial requirements, client-supplied methods, in-house methods or methods specified in published standards, as required by the appropriate Regulatory Authority.
Cawthron Institute Private Bag 2
Nelson 7042
  1. The microbiological, chemical and physical laboratory assessment of raw materials, including purified water, in-process and finished products for:
    • Nutritional or 'nutraceutical' (vitamin, mineral & herbal) products where minor therapeutic claims are made, including products intended for the Australian market where they are termed ‘listable’.
    • Related products intended for the New Zealand market, as defined in the Medicines Act 1981.
  2. The analytical instrumental techniques as applied to 1:
    • Spectrometry (UV/Visible & FTIR)
    • Gas chromatography
    • High performance liquid chromatography
    • Thin layer chromatography
    • ICP-OES
  3. The storage of stability samples under ICH conditions

    All testing performed according to pharmacopoeial requirements, client-supplied methods, in-house methods or methods specified in published standards, as required by the appropriate Regulatory Authority.
Environmental Science and Research Ltd Kenepuru Science Centre
PO Box 50348
Porirua 5240
  1. Laboratory assessment of medicines, medical devices and cosmetics including:
    • Chemical testing of products and raw materials
    • Physical testing
    • Microbiological testing including sterility and limit testing
  2. Instrumental techniques as applied to 1:
    • Spectrophotometry (UV/Visible)
    • High Performance Liquid Chromatography
  3. Storage of stability samples under ICH conditions.

    All testing performed according to: pharmacopoeial requirements, client-supplied methods, in-house methods or methods specified in published standards
Eurofins NZ Laboratory Services Ltd PO Box 12545
Penrose
Auckland 1642
  1. The chemical and physical laboratory assessment and microbial limit testing of raw materials, including purified water, in-process and finished products for:
    • Nutritional or ‘nutraceutical’ (vitamin, mineral & herbal) products where minor therapeutic claims are made, including products intended for the Australian market where they are termed ‘listable’
    • Medicinal products including those intended for the Australian market where they are termed registered medicines.
  2. The analytical and instrumental techniques as applied to 1:
    • Wet Chemistry
    • Titrimetry
    • pH
    • Refractive index
    • Polarimetry
    • Residue on ignition
    • Sulphated Ash
    • Loss on drying
    • Thin Layer Chromatography (TLC)
    • Karl Fisher moisture content
    • Brookfield Viscometry
    • UV/Visible Spectrometry
    • Gas Chromatography (GC)
    • High Performance Liquid Chromatography (HPLC)
    • Fourier Transform Infrared Spectroscopy (FTIR)
    • Atomic Absorption Spectroscopy (AAS)
    • Leco Nitrogen analysis
    • Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES)
  3. Microbiological analysis according to APHA, client methods and CTMAA methodology as specified for sunscreen products for export to Australia.
  4. Storage of stability samples under ICH conditions within environmental chambers at 31b Fairfax Ave. Auckland (excluding chemical testing of stability samples).

    All testing performed according to pharmacopoeial requirements, client-supplied methods, validated in-house methods or methods specified in published standards, as required by the appropriate Regulatory Authority


1. Please note that the scope of Certification has been summarised, please contact the Laboratories directly to discuss the scope of their Certification.