Compliance

Revised: 15 April 2013

Introduction to the New Zealand Code of Good Manufacturing Process for Manufacture and Distribution of Therapeutic Goods

Part 1: Manufacture of Pharmaceutical Products (2009)

Introduction

Good Manufacturing Practice (GMP) is the term used to describe the systems manufacturers of medicines are required to have in place to ensure their products are consistently safe, effective and of acceptable quality. The requirements are expressed in a code of practice referred to as a Code of GMP.

On 1 September 2009 the Pharmaceutical Inspection Convention / Pharmaceutical Inspection Co-operation Scheme Guide to Good Manufacturing Practice PE 009-8, parts I, II and Annexes 1 to 3, 6 to 15, 17, 19 and 20 were adopted as the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods Part 1: Manufacture of Pharmaceutical Products (the Code). The version of the Code currently effective in New Zealand is located on the Medsafe website.

The Code is used by Medsafe to determine whether applicants for Licences to Pack Medicines or Licences to Manufacture Medicines meet appropriate standards pursuant to the Medicines Act 1981 and Medicines Regulations 1984. The code is also used by Medsafe to determine whether applicants for GMP Certificates meet an appropriate standard of GMP.

Implementation of the code

The new code came into effect on 1 September 2009. Non compliances with respect to the new requirements in the Code relating to: product quality review, quality risk management and on-going stability testing, will be raised during audits but will not be regarded as deficiencies until 1 September 2010. At initial audits subsequent to the implementation of the Code, plans to achieve compliance with the new requirements will be assessed for acceptability and agreed with Medsafe. Note that the Code does not alter the definition of a medicine in the Medicines Act 1981.

Note that:

Where the Code refers to 'medicinal product' the definition of 'medicine' in the Medicines Act should be applied. The code does not change the current labelling requirements for clinical trials materials distributed in New Zealand. The code does not alter current New Zealand medicines legislation.

Changes to the code

Future changes made by the Pharmaceutical Inspection Co-operation Scheme to the Guide to GMP, PE 009-8, will be reviewed by Medsafe as they occur and a decision on whether the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods Part 1: Manufacture of Pharmaceutical Products should be updated, will be made.

Background

The New Zealand Code of Good Manufacturing Practice was originally published in 1978. In 1993 the then New Zealand Department of Health, with the agreement of manufacturers and distributors in New Zealand adopted the 1992 Pharmaceutical Inspection Convention (PIC) Guide to GMP thus harmonising New Zealand requirements with international best practice. Since that time the concept of Good Manufacturing Practice has been further elaborated with updated guidance and information on new technologies available to regulators and manufacturers through updates to the original international code.

Medsafe acknowledges the permission given by the Pharmaceutical Inspection Cooperation Scheme (PIC/s) to use its current GMP guide as the New Zealand Code and recognises the efforts of the PIC/s members and other regulators in contributing to a code that reflects updated, internationally accepted GMP requirements for pharmaceutical products.

Information about PIC/s can be found at: www.picscheme.org.