GXP

Successful Use of a Contract Microbiology Laboratory | IVT

The client organization is responsible for their product and by good manufacturing practice (GMP) responsible for all data and analysis that contribute to the decision to release a batch of product to the marketplace. Contract lab reports must provide sufficient information to meet regulatory expectations. Regulatory agencies are increasingly attentive to the relationship between the product’s owner and any contract facility used in the manufacture and testing of finished product for release. Unwanted regulatory attention can be drawn to products if the contract laboratory is involved in enforcement...

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