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AgVetLink: Number 58, October 2006

GMP Notices for Registrants

Contract packers

Recent audits of contract packers have highlighted some areas of concern, such as:

• packing of products unknown to the ACVM Group

• changed packing sites

• imported product being relabelled without proper process.

Registrants must get approval from the ACVM Group for contract packers and for products being packed (including promotional packs). Registrants are also expected to have a FORMAL contract* with a packer so all components of the process are clear. Because GMP is the only regular post-registration compliance check, information needs to be current.

* Refer to the ACVM GMP Standard and Guideline for details of what should be included in the contract.

Direct sale review

Registrants/manufacturers of PAR products may sell directly to end users under the prescription or authorisation of a veterinarian. This type of trading will be reviewed, as required, as part of the routine GMP audit programme of manufacturers. A monitoring (slice of life) programme based on random sampling of organisations to assess compliance to the ACVM standard and the organisation’s quality system will be implemented. The programme will be used to determine if random monitoring is sufficient or if there is a need for a regular monitoring programme (and the frequency of any such programme).