What is Validation?


Documented series of actions that prove that any procedure, process, equipment, material, activity or system perform its intended functions adequately and consistently and lead to expected result of uniform batches that meets the required specifications and quality attributes.

Importance of Validation

Validation studies are an essential part of c GMP and should be conducted in accordance with predetermined protocols. As written report summarizing recorded results and conclusion should be prepared and stored, Process and procedures should be established on the basis of validation study. Validation often requires joint efforts — planning & expertise from several groups, of departments that helps to perform the validation exercise and documentation includes formulation development, Engineering, production, Quality assurance & quality control.


It involves the repeat of initial process validation to provide assurance that changes in the process and/ or in the process environment, whether intentional or unintentional, do not adversely affect the process characteristics and product quality.

Since the plans will be in place the day the deal closes, the merged company can immediately begin implementing the synergy projects needed to realize the value it is seeking.

The validation master plan is a written plan stating how validation will be conducted, including test, Parameters, product characteristics, production equipment and decision points on what constitutes acceptable test results.