Revised: 2 July 2013

Consultations

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 Pharmaceutical Products .

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.

  1. Name of organisation
  2. Name and designation of person completing the response.
  3. 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.
  4. 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: askmedsafe@health.govt.nz

The mail address for comments is:

Attention: Leah Russell
Senior Advisor, Compliance Management
PO Box 5013
Wellington
New Zealand

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:

Derek Fitzgerald
Manager, Compliance Management
email: askmedsafe@health.govt.nz
phone: (04) 819 6866

Leah Russell
Senior Advisor, Compliance Management
email: askmedsafe@health.govt.nz
phone: (04) 819 6862

The deadline for receipt of comments is close of business Friday 15 May 2009

Appendix 1.

Update to the Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods, Part 1: Manufacture of Pharmaceutical Products

  1. Introduction

    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 regulators.

    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.
  2. 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.
  3. Details of the proposal

    1. 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 PIC/s GMP Guide 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 section.
      • Part I: Basic requirements for medicinal products
      • Part II: Basic requirements for active pharmaceutical ingredients
      • Annexes
        • Annex 1 Manufacture of sterile medicinal products
        • Annex 2 Manufacture of biological medicinal products for human use
        • Annex 3 Manufacture of radiopharmaceuticals
        • Annex 6 Manufacture of medicinal gases
        • Annex 7 Manufacture of herbal medicinal products
        • Annex 8 Sampling of starting and packaging materials
        • Annex 9 Manufacture of liquids, creams and ointments
        • Annex 10 Manufacture of pressurised metered dose aerosol preparations for inhalation
        • Annex 11 Computerised systems
        • Annex 12 Use of ionising radiation in the manufacture of medicinal products
        • Annex 13 Manufacture of investigational medicinal products
        • Annex 14 Manufacture of products derived from human blood or human plasma
        • Annex 15 Qualification and validation
        • Annex 17 Parametric release
        • Annex 19 Reference and retention samples
        • Annex 20 Quality risk management

        The following annexes are not proposed for adoption at this time:

        • Annex 4 Manufacture of veterinary products other than immunologicals
        • Annex 5 Manufacture of immunological veterinary products
        • Annex 16 Qualified person and batch release
    2. 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.
    3. 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.

      Note: it is Medsafe's intention to apply for PIC/s membership.
    4. Implementation:

      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.
    5. 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

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