Quality & Compliance

Douglas Pharmaceuticals is committed to 100% compliance with internationally recognised quality systems and good manufacturing practices. Our customers have the highest degree of assurance that our products are manufactured and controlled to the levels required by the world’s most demanding health authorities.

Quality and compliance proof points:

  • Our manufacturing operations are conducted in accordance with the current requirements of the internationally recognised ‘PIC/S (Pharmaceutical Inspection Cooperation Scheme) Guide to Good Manufacturing Practice for Medicinal Products’.
  • All facilities, systems and procedures are regularly inspected by the New Zealand Ministry of Health. Consequently, we have a manufacturing licence and GMP (Good Manufacturing Practice) certificate issued by New Zealand’s national authority.
  • We are also licensed by New Zealand’s national authority to manufacture veterinary medicines.
  • Through a mutual recognition agreement between New Zealand and the European Union (EU), we are able to export our products directly into the EU without them needing re-control.
  • We are a registered pharmaceutical manufacturer with the Australian Therapeutic Goods Administration (TGA).

Our quality control and quality assurance systems have been successfully inspected by the USA FDA (United States Food and Drug Administration). The result of our most recent inspection was that no Form 483 was issued.