Revalidation in Pharmaceuticals

1.0 Definition

Revalidation is the process that ensures any changes made intentionally or unintentionally that brings a change in process or in the process environment should not affect the product quality or process characteristics.

Revalidation is given under two categories. They are periodic revalidation which is carried out at scheduled intervals and revalidation which is done after any change which impacts product quality.

1.1 Revalidation after change:

When any change is introduced which impacts the manufacturing process or any standard procedure then revalidation is performed. Changes like starting material, manufacturing process, packaging material, manufacturing areas, support systems or in process controls are included. Every change should be scrutinized by a qualified validation team by justifying revalidation.

In this type of revalidation, changes may be done in accordance with performance of tests on sub processes and activities of original validation.

1.1.1 Revalidation is needed during the following changes:

• Changes in physical properties of starting materials which alters the mechanical properties thus affecting the product or the process
• Changes in packaging materials which may impact stability of product
• Changes in process like changes in drying temperature, mixing time which impact quality of the product
• Changes in equipment like maintenance, repair or any replacement of major components may impact the process
• Changes done during audit or self-inspection
• Changes in support system or production area

1.2 Periodic revalidation:

Changes in process may occur even if it is carried by following established procedures. Wear and tear of equipment parts may cause changes. Therefore revalidation should be done periodically even if notable changes are not made.

Based on past data periodic revalidation is done by observing the trend in the data.

1.2.1 By following the few points periodic revalidation is done when:

• Changes in master formula or methods or batch size which tends to show impact on product
• Preventive maintenance and calibration are done in par with time and program schedule
• Changes made during analytical control methods 
• Updating and Implementing SOPs
• Implementation of cleaning and hygiene programmes

Revalidation, periodic revalidation, quality

• who expert committee on specifications for pharmaceutical preparations - who technical report series, no. 863 - thirty-fourth report. essential medicines and health products information portal. http://apps.who.int/medicinedocs/en/d/js5516e/16.4.html. updated 14 april, 2016. accessed 16 june, 2016.