Change control is a critical component of quality management in the highly regulated life sciences industry. A change can include procedural change or a process change. It is a formal and systematic approach to manage all changes with specified controls and policies. A predefined change control process ensures that every change becomes a practice.
cGMP relevant Changes
The life science industries operate as per Current Good Manufacturing (cGMP) Practices stated in several binding as well as non-binding statutory requirements depending on the place of business. As per the cGMP, manufacturers are required to provide written procedures for identification, documentation, appropriate review, and approval of changes in:
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- Raw materials,
- Specifications
- Analytical methods
- Facilities
- Support systems
- Equipment (including computer hardware)
- Processing steps
- Labelling
- Packaging materials
- Computer software
Impact Assessment
While implementing every GMP relevant change, the manufacturers need to assess the potential impact of the change. The organizations can perform impact assessment by evaluating the effect of change on the product's safety and quality.
Classification of Change
Life science manufacturers can develop a change classification procedure based on the severity of the impact that accompanies the change. For example, organizations can classify change as minor or major depending on the scope of the change and its effect on product safety and quality. The change classification enables organizations to use scientific judgement to determine what additional testing and validation studies are appropriate to justify the change in the validated process.
Steps in Change Control Process
The steps in the change control process may vary depending on the nature of the business, but in general, the process includes the following steps:
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- Draft: Document the nature and extent of change in relation to the existing process
- Review: Review by the business units and quality units responsible for implementing the change
- Approval : Approval by the business units and quality units accountable for implementing the change
Post Change Approval
After the change is approved, the manufacturers should:
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- Take measures to revise documents affected by the change
- Evaluate batches produced or tested under the change
- Evaluate the effect on product retest or expiry
- If needed, take up an accelerated stability program
- Inform the customer about the change (for example, drug substance manufacturers should inform drug product manufacturers, and API intermediate manufacturers should inform the drug substance manufacturers)
Regulations that mention Change Control Process
Following regulations and guidelines mention Change Control Process in connection to the life science industry:
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