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AgVetLink: Number 67, April 2008

Qs and As: Contract Laboratories

Who is responsible for compliance?

The responsibility for compliance of the contract laboratory rests with you, the manufacturer. When using a contract laboratory, you need to be confident that the results being supplied are valid, are being performed as registered etc. The lab is, in fact, an extension of your manufacturing operations.

Does IANZ accreditation meet GMP requirements?

International Accreditation New Zealand (IANZ) accreditation is not equivalent to the requirements of good manufacturing practice (GMP) although it does provide some level of assurance regarding quality. IANZ accreditation also can be limited in its scope.

Does IANZ accreditation reduce the need for auditing?

As a manufacturer you may decide to reduce the level of auditing if a lab has IANZ accreditation, but this is a business decision. It is dependent on the tests the lab performs for you and the confidence you have in a particular lab and its understanding of your requirements regarding the testing they are performing under contract.