Plan to update the New Zealand Code of Good Manufacturing Practice

Closes 22 Mar 2021

Opened 22 Feb 2021

Overview

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.

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

Implementation phase for industry

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

Why we are consulting

A review of the current Code has been performed by Medsafe GMP auditors. The holders of Licence to Manufacture Medicines, Licence to Pack Medicines, and GMP certificates are invited to review the proposed documents, in particular, those with direct relevance to your organisation, and provide feedback to Medsafe if necessary.

The public consultation will facilitate input from all relevant stakeholders including Medsafe licensed manufacturers and packers, and product sponsors of therapeutic products. 

Give us your views

Audiences

  • Members of the public
  • Pharmaceutical companies
  • Service providers

Interests

  • Therapeutic products