Published: 22 February 2021
Consultations
Consultation on Plan to update the New Zealand Code of Good Manufacturing Practice
February 2021
Background
Medsafe is adopting the new PIC/S Guide to Good Manufacturing Practices (GMP) PE009-14 to ensure alignment with global regulators and best practice. Other overseas regulators (including the TGA Australia) have adopted the most recent PIC/S Guide to GMP version PE009-14.
We have reviewed the current PIC/s Guide, PE009-14, and summarised our interpretation of the important changes. You are invited to review the new Code PE009-14, our summary document, in particular those parts with direct relevance to your organisation, and our implementation timeframes and provide feedback if necessary.
The PIC/s guide states that; It is recognised that there are acceptable methods, other than those described in this Guide, which are capable of achieving the principles of the Guide. This Guide is not intended to place any restraint upon the development of new concepts or new technologies, which have been validated and provide a level of Quality Assurance at least equivalent to those set out in this Guide. We have provided a summary document to outline what we consider to be significant changes to the GMP guideline, to share our interpretation and assist manufacturers in their own interpretation. It remains your responsibility to be cognisant with the guide and put systems in place to ensure the principles of GMP are met.
Consultation and Feedback
The consultation process will run from the 22 February to 22 March 2021.
Please refer to the link below for more details of the consultation
and feedback process.
https://consult.health.govt.nz/medsafe/update-the-nz-code-of-gmp
Details of the proposed updated Code
Medsafe proposes to adopt the PIC/S PE009-14 Guide
Medsafe is adopting the relevant sections of the current edition, PE009-14, as the standard for GMP audits of the manufacturing and packing of medicines. The relevant sections of the PIC/s GMP Guide are listed below.
- 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 substances and products for human use.
- 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 13 Manufacture of investigational medicinal products.
- Annex 14 Manufacture of medicinal products derived from human blood or human plasma.
- Annex 15 Qualification and validation.
- Annex 17 Real time release testing and 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 3 Manufacture of radiopharmaceuticals.
- Annex 4 Manufacture of veterinary medicinal products other than immunologicals.
- Annex 5 Manufacture of immunological veterinary products.
- Annex 12 Use of ionising radiation in the manufacture of medicinal products.
- Annex 16 Qualified person and batch release. This Annex is specific to the EU GMP Guide and has not been adopted by PIC/S.
- Annex 18 GMP Guide for active pharmaceutical ingredients. The Guide has now been adopted as it is now Part II of the PIC/S GMP Guide.
PIC/s GMP Guide revision history
| Date | Version number | Reasons for revision |
|---|---|---|
| 15 January 2009 | PE009-8 |
|
| 1 September 2009 | PE009-09 |
|
| 1 January 2013 | PE009-10 |
|
| 1 March 2014 | PE009-11 |
|
| 1 October 2015 | PE009-12 |
|
| 1 January 2017 | PE009-13 |
|
| 1 July 2018 | PE009-14 |
|
Proposed method for publishing the Code:
PIC/s frequently update the Guide to GMP to accommodate the emerging technology and products in the industry, address gaps in existing compliance requirements and to facilitate continuous improvements in the way medicines are manufactured. The most recent version is PE009-14. Most countries revise and update their Code of GMP regularly to the PIC/S update, to keep up with changes in the industry, changes to manufacturing, and testing technology. The new version of the PIC/S GMP guide, PE009-14, will be published on the Medsafe website and individuals are invited to download the files from either the PIC/S website or the Medsafe website.
website: https://picscheme.org/en/publications?tri=gmp#zone or the Medsafe website: This will be updated once the consultation is complete.
Medsafe Gap Assessment:
Medsafe auditors have performed our own gap assessment to evaluate the differences between our current GMP Code and PE009-14. We have also reviewed this against the work the TGA has done to ensure we are consistent with other leading regulators.
Implementation
Medsafe will inform industry, if necessary, of any comments after the consultation period, and any actions we are taking in response to these. This will be done prior to the implementation of the new Code on 3 May 2021.
Proposed timing for consultation and implementation
| Activity | Target Date |
|---|---|
| Release proposal for stakeholder consultation | 22 February 2021 |
| Deadline for stakeholder comments The consultation period will start on 22 February and finish on 22 March 2021. | 22 March 2021 |
| Notify stakeholders of final decision | 12 April 2021 |
| Publish updated edition of the NZ Code of GMP on Medsafe website | 19 April 2021 |
| Updated edition of the NZ Code of GMP to come into effect | 3 May 2021 |
| Medsafe will use Code PE009-14 as our terms of reference from 3 May 2021. Any deficiencies identified from this time onward will be referenced against the relevant clauses in the PE009-14. If manufacturers believe a deficiency is new (i.e. relates to a new requirement in PE009-14), a plan may be provided in the audit response proposing a timeline for implementation of corrective actions. Medsafe will assess these timelines and corrective actions with the understanding that in some cases close out of deficiencies relating to new requirements in PE009-14 may take longer than usual to achieve. | 3 May 2021 to 3 November 2021 |
| PE009-14 is expected to be fully implemented by manufacturers from 3 November 2021. | 3 November 2021 |
Link to the review of Code for Consultation
