Process validation (PV)

GMP divides the general 'validation' term into two notions: process validation and equipment/system qualification. Before Process Validation (PV) work can be started, one must complete the qualification of critical equipment and auxiliary systems. Equipment/systems qualification is a part of process validation aimed at documented confirmation of acceptability of equipment, utilities, and premises used for production. The qualification is completed in order to be sure that equipment/system can under no circumstances affect product quality. Essentially, qualification of production equipment/systems is a kind of preventive measure.


Qualification is normally completed in the following steps:
  • design qualification (DQ): documented confirmation that the design of production premises, equipment/systems can be used for the intended purpose;
  • installation qualification (IQ): documented confirmation that the installation of premises, equipment/system was performed in compliance with the approved design;
  • operation qualification (OQ): documented confirmation that the rooms, systems and equipment operate in accordance with their intended use in all allowable operational conditions;
  • performance qualification (PQ): documented confirmation that the rooms, systems and equipment when used jointly operate efficiently and with repeatable results, according to specified requirements and process characteristics.

Validation requires thorough preparation and planning of various steps and stages. According to GMP requirements, manufactures must determine the validation procedure that is needed to confirm verification of critical process parameters. To determine the area and scope of validation, one should use a risk assessment based approach. All validation activities are governed by the manufacturer's General Validation Policy and are documented.


The General Validation Policy includes:
  • validation of production processes;
  • validation of cleaning procedures;
  • validation of analytical methods;
  • validation of control tests in the process of production;
  • validation of computerized systems, etc.

Process validation (PV) is performed in order to prove that a process:
  • operates within the specified parameter limits;
  • ensures efficient output of products with repeatable results;
  • complies with pre-defined specifications and quality properties.

Three approaches may be employed for validation:
  • Prospective Validation;
  • Concurrent Validation;
  • Retrospective Validation;
  • Repeated validation (Revalidation).

Prospective Validation is performed before the product is launched into mass production in order to be sold. It is recommended to carry out Prospective Validation for all processes related to output of products.
Concurrent Validation is performed during mass production of products intended for selling.
Retrospective Validation is a verification of mass production process for the sold product based on production data and data of product lot inspections.
Repeated validation (revalidation) is a repetition of initial process validation in order to guarantee that process (equipment) modifications introduced in line with the change control procedure do not impair process characteristics and product quality.


Repeated validation (revalidation) is performed:
  • on a regular basis within the time frames specified by the company in its Validation Report;
  • in case documentation or production conditions are modified in a way that may affect product quality.

The scope of validation work is determined by the company based on introduced modifications. Process validation results must be documented.
A standard package of validation documentation consists of:
  • Validation Master Plan (VMP);
  • validation File (separately for each object);
    • User Requirement Specification (URS);
    • risk assessment protocol;
    • validation program;
    • validation protocol/report;
    • Revalidation (repeated validation) program (routine, unscheduled).
Upon completion of all validation steps a final validation report is drawn up that specifies, if the process has been completed successfully, that the processes are ready for use and comply with the standards.


Thus, validation provides a manufacturer with a documentary confirmation of the processes (equipment) compliance with the specified requirements. This significantly reduces the risk of mistakes, working time losses to identify and eliminate those mistakes and to introduce the appropriate corrections.
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