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:
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.
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.
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:
After the change is approved, the manufacturers should:
Following regulations and guidelines mention Change Control Process in connection to the life science industry: