This document describes the procedures and requirements for the oversight of changes and the maintaining of adequate historical records of such changes from Third Party Manufacturers (TPMs) where API intermediates and API are manufactured and/or tested.This document is intended to ensure that all change requests are:
Documented appropriately
Assessed to determine impact to product quality, safety, efficacy, and registration requirements
Approved prior to implementation
Evaluated by a representative of the Regulatory Affairs group to determine impact on current registration(s) for the product (when required).
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Third Party Change Control Oversight
