Revalidation
Revalidation involves repeating the original validation effort, or any part of it, and includes investigative review of existing performance data. This approach is essential to maintaining the validated status of the plant, equipment, manufacturing processes and computer systems.
Changes that require revalidation necessitate a Change Control to ensure that a validated stated is restored after the change. Examples of these include, but are not limited to, changes to the following:
- Origin of the starting material (change of supplier)
- Packaging material (e.g., replacement of plastic with glass)
- Process changes (e.g., mixing times, drying temperatures)
- Equipment (e.g., introduction of an automatic detection system)
- Production area and supply systems (e.g., new water plant)
- Moving manufacturing into a new building; and changes to
- Software or computer systems (e.g., new software or a new version of the software is installed)
Note: Replacement with equipment that is functionally equivalent may not require revalidation. For additional information on revalidation and change control, refer to PIC/S document PI 006 chapter 6.7.4.
Next, let’s take a closer look at some examples of change control in the manufacturing environment.