Vendor and Contractor Operation Qualification

Description

Procedure describing the process for qualifying and approving vendors and contractor operators for GMP operations at the firm. The purpose from the document:

All vendor and contractor associated products or systems
operating under GMPs will be evaluated based on the ability to meet specified
requirements including quality and regulatory requirements. This evaluation will
qualify the vendor or contract operation to ensure that all received raw materials
conform to specified requirements and to assure that all intermediates and products
manufactured by contract operations for Company Name are made according to GMPs.

This procedure covers suppliers of all raw materials used under GMP.This procedure also covers GMP contract
operations which includes contract manufacturers also known as third party manufacturers
(TPMs), contract analytical QC laboratories, and other contract operations who
supply services to GMP manufacturing at Company Name.

Included with this package is the Vendor/Contractor Qualification Form as well as an 8-page comprehensive Vendor/Contractor Quality Survey (to perform a paper-audit of vendors).