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AgVetLink: Number 62, June 2007

GMP update

EU

Trish Whitaker, Programme Manager (Peformance Systems), recently met with the EU Inspectors Group Quality Working Party to discuss the Mutual Recognition Agreement (MRA) and other aspects of Good Manufacturing Practice. Points of interest from the discussions, particularly for companies exporting to the EU, include confirmation that:

• the EU is now requiring Active Pharmaceutical Ingredients as well as products to be manufactured under GMP

• the GMP Annexes are being reviewed regularly

• the current New Zealand audits are in line with what EU inspectors are doing, ie 2-3 day detailed inspections that generally find 20-50 non-compliances (mostly minor)

• there is potential for joint audits to verify New Zealand equivalency with EU GMP.

New Zealand

The GMP inspection programme has been set for the year and affected companies have been contacted. New auditors (NZFSA Verification Agency and AgriQuality) are being trained, so you may see new faces in this round of inspections.

We would like to remind you that inspections are on a two-yearly cycle although certificates are issued for three years. This is to insure plenty of time to complete an audit and rectify any non-compliances before a certificate actually expires.