Validation is an integral part of quality assurance. The term validation, in manufacturing, often scares people as a very difficult subject. Actually it is nothing much new but an organized approach for establishing GMP. In Pharmaceutical industry, the term validation and Good Manufacturing Practice (GMP) have become two inseparable concepts and are part of the overall concept of Quality Assurance.
Validation may be defined as a systematic study which helps to prove that the systems, facilities and processes perform the job adequately and consistently as specified. To be more precise, a validated operation is one which has been proved to have the potentials for the manufacture of uniform batches meeting the required specifications.
The term validation can be applied to the design, engineering, construction, pre-commissioning of new pharmaceutical facilities and microbiological validations.