Plan to update the New Zealand Code of Good Manufacturing Practice

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

Why your views matter

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. 

What happens next

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.