Good Manufacturing Practice (GMP)

As part of our commitment to quality, we're proud to have recently achieved GMP accreditation for the Auckland Laboratory against the code of Good Manufacturing Practice (GMP) for manufacture and distribution of therapeutic goods (Part 1: Manufacture of Pharmaceutical products).  We can now provide customers with specialised testing to ensure their GMP manufactured products have the widest market opportunity, highest levels of safety assurance and will:

• be fit for their intended use
• not place the user at risk
• conform to all the statutory legislation and guidelines
• comply with the requirements of the marketing authorisation

Products produced to GMP specifications command the highest levels of confidence and are reliabile and safe. Test methods will have product-specific validation, cover active and excipient ingredients, and ensure no matrix activity that could contribute to false negative or false positive test results. Product release and sale decisions will not be made on invalid results that could have serious downstream consequences.

Scope of GMP certification

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 (includes 'listable' products intended for the Australian market)
• Medicinal products (includes registered medicines intended for the Australian market)

2. The analytical instrumental techniques used are:

• 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 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.