Process Validation for Pharmaceutical Industry

For the Pharmaceutical industry, validation of processes and equipment is crucial; while the FDA doesn’t necessarily demand one, documented evidence should prove to overcome future mishaps. A Validation Master Plan is a document that outlines the areas and systems that require validation, risk assessment and their consistency in the long run. A VMP is essentially useful during audits as it lays down the strategies implemented by the facility.

Standard Operating Procedures (SOPs), production formulas, detailed documentation batch change Control, experimental reporting systems, analytical documents, reports development, validation protocols and reports are an integral part of validation philosophy.

The documentation provides information related to the ongoing operation of the plant and is used for development or modifications. Validation happens at various levels and is of different types.

Prospective validation

As the term suggests, prospective validation is a pre-planned process. This validation is carried out during the development stage Where possible critical situations are identified, the risk is evaluated, the potential causes are investigated and assessed for probability and extent, the trial plans are drawn up, and the priorities set. After which an overall assessment is made; if the results are favorable, the process is satisfactory. This form of validation is essential in order to limit the risk of errors occurring on the production scale, e.g. in the preparation of injectable products.

Concurrent validation
Concurrent validation occurs at the normal stage. This validation establishes that a facility and process will perform as they are intended, based on information generated during actual use of the process. It defines how the product will be managed throughout the process. Concurrent validation process is identical to prospective validation.

Retrospective Validation

Retrospective validation is done on systems that have been operating for a while. Generally during this type of validation, a complete validation process isn’t required. Doing a full validation may not be required; since there is proof that the system functions are as required. However, doing nothing may be a risk. Historical data can certainly be used to support validation.
During retrospective validation, it’s advisable that the product be separated and production should be put on hold until the validation process has been completed.


Revalidation is needed to ensure that changes in the process product quality. Revalidation may be divided into two broad categories:

  • Revalidation after any change bearing on product quality.
    Revalidation must be performed on introduction of any changes affecting a manufacturing and/or standard procedure bearing on the established product performance characteristics. Every such change requested should be reviewed by a qualified validation group, which will decide whether it is significant enough to justify revalidation and, if so, its extent.
  • Periodic revalidation carried out at scheduled intervals
    Process changes may occur gradually even if experienced operators work correctly according to established methods. Equipment wear may also cause gradual changes. Consequently, revalidation at scheduled times is advisable even if no changes have been deliberately made.

Before process validation can be started, manufacturing equipment and control instruments must be qualified. All aspects of manufacturing must be validated, including critical services (water, air, nitrogen, power supply, etc.), and supporting operations, such as equipment cleaning and sanitation of premises. Proper training and motivation of personnel are prerequisites to successful validation.

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