Quality

A reputation for excellence based on attention to detail and a focus on continuous improvement

QUALITY ASSURANCE


The Quality Department includes a Quality Assurance section to ensure compliance with New Zealand and international GMP regulatory requirements and to ensure that the company is continually improving its quality systems and procedures. NZP’s operations are audited periodically by the New Zealand regulatory health authorities as well as by our customers and other national bodies. Customers include world leading pharmaceutical and microbiological media companies. QA staff manage GMP compliance across the site.

 

MEDSAFE


Medsafe has certified NZP for the export of active substances to the EU
(Reference: TT60-234-16-3 EC003)

NZP has Medsafe cGMP compliance certification and holds GMP certificates for a number of products.
(Reference: TT60-234-16-3).

Additionally NZP hold a Medicines licence, issued by the New Zealand Ministry of Health, for cholic acid and ManNAc.
(Licence No. 121/15/1)

 

MINISTRY OF PRIMARY INDUSTRIES


NZP manufactures a range of biochemicals from plant and animal derived tissue. New Zealand remains free of all Class A animal diseases as listed by the OIE. New Zealand’s most up to date animal disease status is available from the Ministry of Primary Industries website (formerly NZFSA). NZP have Risk Management Programme registration with the NZ Ministry of Primary Industries. (Reference: BBP14/03)

 

CAPABILITIES


The Quality team is a key part of our organisation. The department is well equipped with GMP qualified and regularly calibrated instrumentation, providing for a wide range of analyses including:

  • HPLC
  • Capillary headspace GC
  • FTIR
  • UV/vis spectrometry
  • Melting point
  • Optical rotation
  • Karl Fischer titrations
  • Endotoxins
  • TOC

cGMP PRODUCTS


NZP is certified by Medsafe (New Zealand's regulatory body) as a cGMP manufacturer for a number of products:

  • Cholic Acid - API
  • Cholic Acid
  • Deoxycholic Acid
  • Dehydrocholic Acid
  • Sodium Cholate
  • Sodium Deoxycholate
  • Bile Salts No. 3
  • Heparin Sodium (Porcine)
  • N-Acetyl-D-mannosamine
 
 

QUALITY CONTROL


The QC team ensures that all raw materials are fit for use in the manufacture of NZP’s high quality products. All finished product batches are subjected to full QC testing to ensure they meet pharmacopoeial or customer specifications.