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GMP Certified Contract Testing Laboratories

Last Updated:  14 July 2006

Company Name Postal Address Scope Summary1
AgriQuality Limited 131 Boundary Road
Blockhouse Bay
Auckland
New Zealand
  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’
  • · Medicinal products including those intended for the Australian market where they are termed registered medicines.
  1. The analytical instrumental techniques as applied to 1:
  • UV/Visible Spectrometry
  • Gas Chromatography (GC)
  • High Performance Liquid Chromatography (HPLC)
  • Thin Layer Chromatography (TLC)
  • ICP-MS (mass spectrometry)
  • ICP-OES (optical emission spectrometry).

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.

Apotex New Zealand (Lab) Private Bag 102995
North Shore Mail Centre
AUCKLAND
  1. Testing of raw materials intended for medicine manufacture
  2.  In process testing of medicines
  3. Release testing of finished product (medicines)
  4. Identity testing of bulk product
  5. Stability testing.
Cawthron Institute 98 Halifax Street East
Private Bag 2
Nelson
New Zealand
The microbiological, chemical and physical laboratory assessment of: raw materials, including purified water, and in-process and finished nutritional or 'nutraceutical' (vitamin, mineral & herbal) products

Certification applies to various analytical instrumental techniques 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'.

ESR Pharmaceutical Programme
Kenepuru Science Centre
P O Box 50-348
PORIRUA
  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

Certification applies to various analytical instrumental techniques

  1. Laboratory assessment of condoms and gloves (examination and surgical)
New Zealand Laboratory Services Ltd. P O Box 12-545
Penrose
AUCKLAND
Microbiological analysis according to APHA, client methods and CTMAA methodology as specified for sunscreen products for export to Australia.
(a) Physical and chemical analysis of active and excipient raw materials for use in pharmaceutical and therapeutic products including complementary medicines, neutraceuticals termed ‘listable’ for export to Australia.
Analysis of (a) according to pharmacopoeial monographs and validated in-house and customer procedures using the techniques of: wet chemistry, titrimetry, pH, refractive index, polarimetry, residue on ignition, sulphated ash, loss on drying (non-vacuum), thin layer chromatography and Karl Fisher moisture content.
(b) Storage of stability samples under ICH conditions within environmental chambers.


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