When goods or services are purchase by a cGMP approved organization from a none cGMP approved vendor; it is a legal requirement that the would-be purchaser audits the supplier to establish the scope of any work required to render the item or process cGMP compliant
This elevates the Vendor Audit (VA) Document to a “Must be in Place” status. So, your list of pre validation doc's must include: (VA) + (FAT) + (SAT)
These are mandatory & available as a package;
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combination IQ-OQ-PQ protocol has been produced in response to several hundred reader
suggestions we received in our ‘Suggestions Section’. It has been carefully
designed to make it the preferred choice for Process and Laboratory stand alone
equipment. It is interactive, easy to use, compliant with cGMP & GAMP 5. and suitable for all mixes of
equipment with and without software.
The document that sets the standard, and specifies your computer requirements in a manner that ensures when a system or piece of equipment is selected, it will deliver the functions you want, it will have maintenance standards, it will have calibration records, it will have all the documents and records to enable successful validation to be completed. This document was designed to be used as a live document up until the DQ and is compliant with cGMP and GAMP 5.