Validation: Essentials of Pharmaceutical Validation

 Validation:

Validation is a process, specially used in case of pharmaceutical, medical device, food, blood and biological products, 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. It involves the systematic study of systems, facilities and processes aimed at determining whether they perform their intended functions adequately and consistently as specified.

Essentials of Pharmaceutical Validation:

@ Validation is an integral part of quality assurance.It involves the systematic study of systems, facilities and processes aimed at determining whether they perform their intended functions adequately and consistently as specified. 

@ Validation in itself does not improve processes but confirms that the processes have been properly developed and are under control.

@ Adequate validation is beneficial to the manufacturer in many ways:

ü  It deepens the understanding ofprocesses; decreases the risk ofpreventing problems and thus assuresthe smooth running of the process.

ü  It decreases the risk of defect costs.

ü  It decreases the risk of regulatory noncompliance.

ü  A fully validated process may requireless in-process controls and endproducttesting.

@ Validation should thus be considered in thefollowing situations:

-         Totally new process;

-         New equipment;

-         Process and equipment which havebeen altered to suit changing priorities;and

-         Process where the end-product test ispoor and an unreliable indicator ofproduct quality.