JVT

Qualification of a Contract Microbiology Laboratory | IVT

The client organization is responsible for all data and analysis that contributes to the decision to release a batch of product to the marketplace accordng to good manufacturing practice (GMP). Contract lab reports must provide sufficient information to meet regulatory expectations. Several recommendations are provided to increase the likelihood of a successful contractor-client relationship. Most important of these include technically competent review of the lab and the reports received—while the contract lab is working on your product the regulatory expectation is that you are responsible...

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