| 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. |
| 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. |
| New Zealand Institute for Public Health and Forensic
Science Ltd (PHF Science) |
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). |
