The Quality team occupies 250 m2 (≈2700 sq. ft) of modern laboratory and office space to meet the demanding needs of today's analysis and documentation requirements.
The Quality Control laboratory is well equipped and can perform a wide range of analyses including;
- FTIR
- HPLC
- Capillary GC
- UV/vis spectrometry
- NMR (400 & 500 MHz)
- Melting point
- Optical rotation
- Karl Fischer water
- Titrations
- Endotoxins
- TOC
- Product stability testing, etc.
All instruments are GMP qualified and regularly calibrated.
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 pharmacopoeia or customer specifications.
- Before product release for sale, QC conducts a thorough review of relevant production and testing records to ensure compliance with GMP requirements.
Quality Assurance
The Quality team includes a Quality Assurance section to ensure compliance with New Zealand and international GMP regulatory requirements (ICH Q7 guidelines) and to ensure that the Company is continually improving its quality systems and procedures.
NZP's operations are audited annually by the New Zealand regulatory health authorities and its customers.
QA staff manage associated GMP activities including;
- Change control
- Supplier qualification
- Qualification of processing equipment and
- Validation of processes.
Documentation
The Quality team is experienced at preparing Drug Master Files (DMFs) for API products and related activities of establishing appropriate API specifications, validating test methods and conducting accelerated and long term stability studies under ICH conditions.
NZP holds various product DMFs in Europe, USA, Australia and New Zealand.
NZP holds a Certificate of Suitability issued by the European Directorate for the Quality of Medicines (EDQM) for its bile products. The Certificate of Suitability certifies that the product when used in human pharmaceutical applications has an acceptably low risk of transmitting BSE agents and is issued only after EDQM has carried out a full assessment of the raw material type and sourcing and the nature of the manufacturing processes used.
The New Zealand Government's Ministry of Health division called Medsafe, http://www.medsafe.govt.nz/, undertakes the medicines licence audit for the 7 API compounds manufactured at NZP. Medsafe also audits NZP every year to certify NZP's 20 GMP products.