Change Control is part of a company’s GMP Quality Management System (QMS) and ensures that 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 manufacturing activities to remain unaltered. However, it is equally unreasonable to allow uncontrolled changes to manufacturing process steps, equipment, methods, and specifications 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 potential effect of changes on Marketing Authorisations (MA) means the regulatory impact is a critical part of the change evaluation 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.

Failure to adequately assess and implement changes in MAs is one of the main contributing factors for registration drift.

Change control and GMP 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.

Some of the key elements of GMP QMS include:

  • Change control
  • Deviations/OOS
  • Complaints and recalls
  • Validation (process, equipment, facilities, and utilities)
  • Training
  • Auditing (including self-inspections)
  • Documentation and records