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​ pharmaceutical validation

Assuring a higher degree of quality of drug products.

Pharmaceutical Validation


Validation is a process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in production or testing maintains the desired level of compliance at all stages. In Pharma Industry it is very important apart from final testing and compliance of the product with the standard that the process adapted to produce itself must assure that process will consistently produce the expected results. Here the desired results are established in terms of specifications for the outcome of the process.


Qualification of systems and equipment is, therefore, a part of the process of validation. It is a requirement of food and drug, pharmaceutical regulating agencies like FDA's good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections.


Validation Subsections:



Equipment Validation

Facilities Validation

HVAC System Validation

Cleaning Validation

Process Validation

Analytical Method Validation

Computer System Validation

Packaging Validation

Cold Chain Validation



Similarly, the activity of qualifying systems and equipment is divided into a number of subsections including the following:

Design Qualification (DQ)

Component Qualification (CQ)

Installation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ)