| Company Name |
Postal Address |
Site Address |
Scope Summary 1 |
| AsureQuality Ltd |
PO Box 41
Shortland Street
Auckland 1140 |
131 Boundary Road, Blockhouse Bay, Auckland. |
- 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.
- 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)
- The storage of stability samples under ICH guidelines.
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 |
52 Carrington Road, Point Chevalier, Auckland. |
- The microbiological laboratory assessment of medicines,
medical devices and raw materials (including purified water),
in-process samples and finished products.
- 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 |
78 Ascot Road, Mangere, Auckland |
- Chemical and physical laboratory assessment of raw materials, in-process and finished products for:
- Nutritional or ‘nutraceutical’ (vitamin, mineral and 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.
- Physical test methods as applied to 1:
- Friability
- Hardness
- Disintegration
- Dissolution
- Chemical assessments and analytical instrumental techniques as applied to 1:
- Spectrometry (UV/Visible & FTIR)
- Gas Chromatography
- Liquid Chromatography
- Karl Fisher
- pH
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.
|
| Cawthron Institute |
Private Bag 2
Nelson 7042 |
98 Halifax Street East, Nelson. |
- 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.
- The analytical instrumental techniques as applied to 1:
- Spectrometry (UV/Visible & FTIR)
- Gas chromatography
- High performance liquid chromatography
- Thin layer chromatography
- ICP-MS
- 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 |
Kenepuru Science Centre, 34 Kenepuru Drive, Porirua, Wellington. |
- Laboratory assessment of medicines, medical devices and
cosmetics including:
- Chemical testing of products and raw materials
- Physical testing
- Microbiological testing including limit
testing, endotoxin and preservative efficacy
- Instrumental techniques as applied to 1:
- Spectrophotometry (UV/Visible, FTIR/NIR)
- High Performance Liquid Chromatography
- 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.
This certificate applies only to the activities undertaken within
the Pharmaceutical Programme and excludes physical testing of condoms
and gloves (surgical and examination). |
| Eurofins BioPharma Product Testing NZ Ltd |
PO Box 12545
Penrose
Auckland 1642 |
35 O’Rorke Road, Penrose, Auckland. |
- 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.
- The following chemistry testing for water samples:
- pH
- Conductivity
- Wet chemistry as per Ph. Eur (for Nitrates and Oxidisable substances).
- Microbiological analysis according to APHA, client methods and CTMAA methodology as specified for sunscreen products for export to Australia.
- Storage of stability samples under ICH conditions within environmental chambers (excluding chemical testing of stability samples).
All testing performed according to pharmacopoeial requirements, validated in-house methods or methods specified in published standards, as required by the appropriate Regulatory Authority. |
