Change Control Process
Change Control is part of a Company’s Quality Management System (QMS) and ensures the validation of the manufacture, testing and release of healthcare and pharmaceutical products is not jeopardised through altering and “improving” some of the approved operating conditions. Throughout the lifetime of a product it is unreasonable to expect a complex series of activities to remain unaltered. However, it is equally unreasonable to allow uncontrolled changes to manufacturing process steps, equipment, methods, specifications, etc. to be implemented without due consideration to wider implications, as this may impact on the final product quality and ultimately patient safety.
The Change Control Process is a series of formal assessments of a potential or proposed change, where the initiator details the nature, scope, purpose and justification for a planned change. This is assessed by all relevant departments, and the impact on different areas of the business is determined. Once the full extent of the impact and actions are known a change can be permitted or rejected.
Change Control and Marketing Authorisation (MA)
The effect on Marketing Authorisation (MA) by Change Control means the regulatory impact is a critical part of the process. Whilst many manufacturing changes are unlikely to affect the registration details, others reported and detailed within the CTD require updating, through License Variation and the product’s Life Cycle Maintenance.
Change Control and Quality Systems
Quality Systems required prior to product commercialisation are controlled and regulated to guarantee the manufacture, testing and release of a product is consistent batch after batch. Validation is also used to identify weak areas of the manufacturing process to ensure they’re either remediated or managed, and to eliminate any effect on the final product. Once validated, it is critical that the validated state is maintained. Although Change Control was originally designed to control and manage manufacturing site based changes, its applicability spans the entire business operations and is indeed a critical component for the avoidance of Registration Drift.
How Woodley BioReg can help with Change Control
Woodley BioReg helps pharmaceutical, biopharmaceutical and healthcare companies develop their skills through training in the full range of cGMP Quality Systems including Change Control at the plant and affiliate levels. WBR also works with a number of clients to deliver License Maintenance, and management and control of Registration Drift, offering advice on determination, remediation and the implementation of sustainable solutions for on-going conformance. Companies expend huge resources, both financially and in “man hours”, on validation activities for manufacturing processes and products; Woodley BioReg can supply Flexible Resourcing Solutions to provide this on a short and long-term basis at your site and remotely.
For more information on Change Control Process please contact us.