Revised: 2 July 2013
Proposed update to the New Zealand Code of Good Manufacturing Practice
Medsafe is seeking feedback from the sector on its proposed update to Part I of the
Code of Good
Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods, Part 1: Manufacture of
You are requested to review the proposed documents, in particular those with direct relevance to your
organisation, and provide feedback to Medsafe.
Feedback is requested by 15 May 2009.
To assist with the analysis of feedback, it would be helpful if submitters could prepare their response
by grouping the information under the following headings.
- Name of organisation
- Name and designation of person completing the response.
- Please describe specific difficulties or perceived advantages that the new or revised requirements
of the code may present to your organisation. Please reference the chapter name, title and section
number where appropriate.
- If your organisation exports medicines, please comment on the suitability of the proposed Code for
your intended export markets.
Comments may be sent by email or mail and should include your full contact details.
The email address for comments is: Leah_russell@moh.govt.nz
The mail address for comments is:
Attention: Leah Russell
Senior Advisor, Compliance Management
PO Box 5013
Comments should be clearly headed as relating to the Code of GMP.
If you have any questions about this proposal please direct them to either:
Manager, Compliance Management
phone: (04) 819 6866
Senior Advisor, Compliance Management
phone: (04) 819 6862
The deadline for receipt of comments is close of business Friday 15 May 2009
Update to the Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic
Goods, Part 1: Manufacture of Pharmaceutical Products
Part 1 of the Code is made up of the basic requirements (chapters 1 to
9), annexes describing specific requirements (annexes 1 to 10) and Guidelines for the Manufacture of
Active Pharmaceutical Ingredients.
The basic requirements and annexes are based entirely on the 1992 Pharmaceutical Inspection Convention
(PIC) Guide to Good Manufacturing Practice. The Guidelines for the Manufacture of APIs are based
entirely on the 1987 PIC guidelines.
In the intervening years the Pharmaceutical Inspection Co-operation Scheme (PIC/s) has published
subsequent versions of the basic requirements, version updates and new annexes, and expanded guidelines
for APIs which incorporated international developments in GMP as discussed and agreed by member
A review of the current Code has been performed and it has been noted that:
- There have been significant developments in international codes of GMP which are not addressed
in the current New Zealand Code and New Zealand requirements are diverging from those of key trading
partners; for example countries of the European Union and Australia.
- A number of manufacturers in New Zealand have requested GMP certification referencing other
codes of GMP in recognition of this divergence.
- Reason for the update
The proposed Code update is intended to:
- Incorporate developments in international codes of GMP.
- Address developments with respect to new or improved technologies.
- Ensure the New Zealand requirements and New Zealand manufacturers remain up to date in an
increasingly global manufacturing environment.
- Improve the specific guidance available for particular sectors of the industry, for example,
manufacturers of sterile medicines, and manufacturers of active pharmaceutical ingredients.
- Improve the guidance available for key components of Quality Management, for example, validation
and qualification activities.
- Support the provision of GMP certification to New Zealand's Mutual Recognition Arrangement
partners on behalf of New Zealand manufacturers exporting medicines to other countries.
- Details of the proposal
- Proposed Code
It is proposed to continue to base the NZ Code on the PIC/s Guide
to GMP and adopt the relevant sections of the current edition, PE 009-8, as the standard for GMP
audits of manufacture and packing of medicines by Medsafe GMP auditors. The relevant sections of the
are listed below. You can download the documents at no cost from the PIC/s
website: http://www.picscheme.org/ in the PIC/S Guides
- Proposed method for publishing the Code:
The currently accepted version of the PIC/s GMP guide will be
published on the Medsafe website and individuals invited to download the files at no cost.
- Mechanism for updating the Code
The PIC/s Guide to GMP is periodically revised to include changes
determined necessary by PIC/s member regulators. It is proposed that each amendment to the PIC/s GMP
guide is reviewed within Medsafe and accepted for inclusion within the NZ Code where relevant.
it is Medsafe's intention to apply for PIC/s membership.
It is Medsafe's intention to discuss with individual
manufacturers, as necessary, changes that may be required in order to comply with the new Code.
- Proposed timing for consultation project
|Release proposal for stakeholder consultation
||16 March 2009
|Deadline for stakeholder comments
||15 May 2009
|Notify stakeholders of final decision
||14 June 2009
|Publish updated edition of the NZ Code of GMP
||1 July 2009
|Updated edition of the NZ Code of GMP to come into effect
||1 September 2009
Review of Code for Consultation - March 2009