Qualification and Validation In Pharmaceutical Manufacturing


EU GMP - it is “Action of proving, in accordance with the principles of Good Manufacturing Practice (GMP), that any procedure, process, equipment, material, activity or system actually leads to expected results.


Performed to establish evidence that process equipment and ancillary systems are capable of operating within established limits and tolerances.

Provides documented evidence that the subject equipment has been installed as per specification (manufacturer’s recommendation) and will attain and maintain critical process parameters repeatedly and reliably.

Comparison between Qualification and Validation

- Qualification is normally used for equipment, utilities and systems.

- Validation is normally used for processes and methods.

- Qualification is often a part (the initial stage) of validation but the individual qualification steps alone do not constitute process validation.

- Process validation cannot take place without first carrying out qualification


  • To assures Quality
  • For regulatory Requirement
  • To reduces Cost

What to Qualify/Validate?




-Test Methods



Validation Documentation

-Validation Master Plan (VMP)

-Validation Protocols (VP)

-Validation Reports (VR)

-Standard Operating Procedures (SOPs)

1. Validation Master Plan:

- Contains key elements of the validation program.

- Summary of facilities, systems, equipment and processes validated (and to be validated)

2. Validation Protocol:

- Is a detailed document relating to a specific part of the validation process.

- Describes the procedure to be followed for performing validation.

- Description of the equipment to be used (including calibration before and after validation).

3. Validation Report:

- Record of results obtained during the performance of the validation.

- Includes evaluation, analysis and comparison of results with acceptance criteria by the responsible personnel.

- Results should meet acceptance criteria and satisfy the stated objective.

Types (Stages) of Qualification

- Design qualification (DQ)

- Installation qualification (IQ)

- Operational qualification (OQ)

- Performance qualification (PQ)

Changes that require revalidation:

- Site changes; Operational changes

- Change of source of material

- Change in the process

- Significant equipment change

- Production area changes

Types of Validation 

- Process Validation 

- Analytical Method Validation

- Cleaning Validation

- Water Systems Validation

- Computerized System Validation

Read in details: Process Validation in Pharmaceutical Industry

Note: PV should be completed prior to commercial manufacturing. Where this is not possible, it may be necessary to validate processes during routine production.

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