In the pharma industry, changes need to be reported through a change control system in quality control, production, stores, quality assurance, engineering, and R & D departments. Therefore, change control comes with an essential role in pharmaceuticals.
Change control defined
Change control is necessary for controlling changes made in the pharma industry. If change was made in any procedure, it is reported through the change control procedure. Change control is a concept by cGMP for change management to avoid unintended consequences. The change can be deletion of, addition to, or modification of manufacturing utilities, facility, material, process, procedures, product, or equipment that impact regulatory requirements or quality.
Why change control procedure in the pharma industry is important?
Change control aims to avoid unintended consequences when making changes to a system or product. Change control procedure is essential for the following reasons.
It demonstrates compliance to regulatory agencies
Tracking and documenting details of the change
Systematic and structured approach for change management with correct change evaluation
Routing of change requests to proper team/ individuals for approvals
Change control procedure
Usually, a change control procedure starts with a change proposal initiated by a department personnel with proper justification. Then, the change proposal will be evaluated by a professional team (change control committee). After the change evaluation, the change will be classified by a quality unit.
Change classification benefits
Change classification can be beneficial for the assessment of the impact of change in a reliable way. It can also help to determine the risks related to every change request. Through change classification, change acceptability can be determined.
In addition, change classification can trigger impact analysis of the change to determine the impacted documents and systems. Keep in mind that every change proposal comes with several risks, including reduced product quality. So, assessment of risks in changing requirements is essential to produce the best change results.
The change control procedure should ensure that the effort and documentation level were matched to the associated risk with the change. In addition, the change control needs to be associated with other quality systems like customer complaints, CAPA, validation, and more.
Criteria when change control can be applied
Change control can be taken for the criteria below:
- Change in protocol
- Change in utilities
- Change in batch manufacturing record
- Change in retest or expiry date and more
Changes except for changes in analytical methods, specifications, batch manufacturing, master formula, and changes in regulatory affairs should be handled by the corporate QA (quality assurance.)
Change control procedure is necessary for pharmaceutical companies for change control. In addition, regulatory authorities like EMA and FDA require companies to change control procedures since it’s a part of the Quality Management System (QMS).
The changes in the manufacturing procedure, like changes in materials or equipment, should be validated. Thus, it can impact the quality of the product. But, more importantly, there should be written processes for process control and production to ensure that the products come with strength, identity, purity, and quality.
The written procedures which involve the changes need to be drafted, reviewed, and approved by the right organizational units. Then, it will be review and approved by the quality control department.