Revalidation of Pharmaceutical Processes : Pharmaguideline

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Revalidation of Pharmaceutical Processes

Know about the conditions and changes due to which revalidation of a process is necessary.
Revalidation of any process is an essential part of the validation. It improves the quality of the product and increases the smoothness of the process.
There are various conditions in which it is essential to revalidate the process. Revalidation is done in two conditions.
A. Periodic Revalidation
B. Revalidation after any change

A. Periodic Revalidation: Periodic revalidation is done to identify the change in process that may happen during a period of time. There may be any change in standard operating procedure, master formula, specification, calibration, analytical method etc during the period. These all should be considered during the periodic revalidation.

Revalidation in Pharmaceuticals
B. Revalidation after any change: Revalidation should be done after any change that can affect the quality of the product. Following changes should be followed by the revalidation.

1. Any change in raw material including the physical properties as changing the bulk density, viscosity and the particle size of the material because these can alter the dissolution and the disintegration of the product manufactured.

2. If the source of the raw material is changed as the manufacturer of the material is changed because the quality of the raw material may change due to the change in the manufacturer. This may also affect the quality of the product.

3. If the type of the packing material is changed. For example, if we change the glass bottle to the plastic bottle or PVDC to Alu-Alu.

4. If manufacturing procedure is changed as any change in the mixing or blending time, change in RPM, change in the coating process, change in time for drying etc.

5. Any change in process equipment as the automatic system is installed in place of manual, additional feature is added in any instrument etc.

6. Any change in the production system or change in the utility used in the process as a major change in HVAC system or any change in the water system, relocation of any equipment or instrument etc.

7. Any change required in the process due to the change in the technology.

The condition in which revalidation is not required: if any instrument or equipment is changed with the same type of the instrument or equipment or the equipment is upgraded to the new version or model.
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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  1. For scheduled revalidation is it required to perform stability study of the revalidated batches?

  2. What is the frequency of periodic revalidation?


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