The purpose of this SOP is to describe in detail the change control process flow, starting with a request for a change following necessary assessments and approvals. This standard process ensures that all planned changes related to any aspect of manufacture, testing and distribution are reviewed, assessed and approved by technical and quality competent site personnel, which includes Quality Assurance. The main task is to evaluate potential impacts followed by correlative consequences of the requested change on product quality, current Good Manufacturing Practice (cGMP), including qualification and validation and the regulatory file/dossier before approval and implementation of a change control request.
This procedure applies to all new and existing manufacturing/packaging processes, utilities, major equipment, computerized systems, facilities, drug products, drug substances, medical devices, raw materials, components, testing requirements, specifications and systems for marketed products and clinical trials (clinical, preclinical and stability with GMP implications). Documents and systems that may be impacted by a given change in any of these areas include, but are not limited to, all master documents, Marketing Authorization Applications (MAA’s), New Drug Applications (NDA’s), validation, stability protocols and control systems.
Copyright 2011 by Standard Operating Procedure