Good Manufacturing Practice (GMP) Certification
As part of our commitment to quality, we're proud to have Good Manufacturing Practice (GMP) accreditation for the Auckland Laboratory against the code of GMP for manufacture and distribution of therapeutic goods (Part 1: Manufacture of Pharmaceutical products).
Ensure Your Raw Materials are Suitable for Manufactured Products
We can now provide customers with specialised testing as per pharmacopoeia standards to ensure their raw materials are suitable for the manufactured products and 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
Value of meeting GMP specifications
Products produced to GMP specifications command the highest levels of confidence and are reliable and safe. Test methods will have product-specific validation, cover actives and excipients, 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
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)
- Validation of analytical methods for Chemical and Microbiological analyses for finished products (validation according to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Harmonised Tripartite Guideline).
Analytical instrumental techniques used for GMP Certification
- 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 pharmacopoeia requirements, client-supplied methods, in-house methods or methods specified in published standards, as required by the appropriate regulatory authority.
