Process Validation in Pharma - Definition and Types of Process Validation

Definition:

Process Validation (PV) is the documented evidence that the process, operated within established parameters, can perform effectively and re producibly to produce an intermediate or API meeting its predetermined specifications and quality attributes as per ICH Q7 guideline.

Requirement: why it performed:

The critical parameters/attributes should is identified during the development stage or from historical data, and the ranges necessary for the reproducible operation should be defined. This should include:

Defining the API in terms of its critical product attributes;

Identifying process parameters that could affect the critical quality attributes of the API;

Determining the range for each critical process parameter expected to be used during routine manufacturing and process control.

Validation should extend to those operations determined to be critical to the quality and purity of the API.

    Types of process validation:

(1)  Prospective Validation

(2)  Concurrent Validation

(3)  Retrospective Validation.

(4)  Re validation.

      Prospective Validation:

      Prospective validation should normally be performed for all API with new process

     Concurrent Validation:

    Concurrent validation can be conducted when data from replicate production runs     are unavailable because only a limited number of API batches have been produced, API batches are produced infrequently, or API batches are produced by a validated process that has been modified.

Retrospective Validation:

Retrospective validation based on the available data and the examination of past experience of production. When validation is not performed previously. 

Re validation:

Re validation is performed when any change in process, equipment or any raw material or route of  synthesis.