Revalidation after change

11.23 Revalidation should be performed following a change that could have an effect on the process, procedure, quality of the product and/or the product characteristics. Revalidation should be considered as part of the change control procedure.

11.24 The extent of revalidation will depend on the nature and significance of the change(s).

11.25 Changes should not adversely affect product quality or process characteristics.

11.26 Changes requiring revalidation should be defined in the validation plan and may include:

• changes in starting materials (including physical properties, such as density, viscosity or particle size distribution that may affect the process or product); change of starting material manufacturer;

• transfer of processes to a different site (including change of facilities and installations which influence the process);

• changes of primary packaging material (e.g. substituting plastic for glass);

• changes in the manufacturing process (e.g. mixing times or drying temperatures);

• changes in the equipment (e.g. addition of automatic detection systems, installation of new equipment, major revisions to machinery or apparatus and breakdowns);

• production area and support system changes (e.g. rearrangement of areas, or a new water treatment method);

• appearance of negative quality trends;

• appearance of new findings based on current knowledge, e.g. new technology;

• support system changes.

Changes of equipment which involve the replacement of equipment on a “like-for-like” basis would not normally require a revalidation. For example, installation of a new centrifugal pump to replace an older model would not necessarily require revalidation.