Published: 13 December 2017

The Medsafe Files — Episode Four: New Medicines Assessment (Part 3): GMP

Prescriber Update 38(4): 56-57
December 2017

Key Messages

  • Medicines that are approved for supply in New Zealand must be manufactured in accordance with Good Manufacturing Practice (GMP).
  • GMP helps to ensure that medicines are of high quality and are fit for use
  • Unapproved products may not have been manufactured under GMP.
  • Medsafe performs site audits to verify compliance with GMP.

Good Manufacturing Practice (GMP) is the part of Quality Assurance which ensures medicines are consistently produced to appropriate standards.

GMP helps to ensure medicines are fit for their intended use, comply with the conditions of their consent, and do not place patients at risk due to inadequate safety, quality, or efficacy. Manufacturing in accordance with GMP ensures that:

Medicine manufacturing and packing sites are audited and licenced by Medsafe.

Medsafe conducts on-site audits of medicine manufacturers in New Zealand against the New Zealand Code of GMP. Auditors observe manufacturing and packing processes and associated records, and evaluate the supporting quality systems. Where a manufacturer is operating in compliance, Medsafe will issue a Licence to Manufacture Medicines and/or a Licence to Pack Medicines.

Medsafe uses a risk-based approach to determine the audit duration and frequency. This takes into account factors such as the inherent risk of the medicines manufactured on-site (eg, sterile medicines are higher risk) and the compliance history of the manufacturer.

Medsafe recognises GMP Certification from other medicine regulators.

Medsafe is a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). PIC/S is an international community of medicine regulators that includes the United States Food and Drug Administration and many European Union regulators. One of the aims of PIC/S is to harmonise the inspection procedures of its members. The New Zealand Code of GMP is aligned with internationally accepted standards.

Medsafe recognises GMP certification issued by a number of other medicine regulators, and Medsafe GMP certification is widely recognised. Mutual recognition enables Medsafe to verify that overseas manufacturers of medicines approved for the New Zealand market meet the requirements of GMP.