Validation: Introduction, Definition, General Principle, Scope

Validation is an essential and integral part of the pharmaceutical industry to produce products of desired quality consistently and economically. It is required for compliance with national or international regulations. It is an important requirement of a quality system to maintain the consistency of quality products in all stages.

USFDA defines validation as the establishment of documented evidence that provides a high degree of assurance that a planned process will consistently perform according to the intended specified outcomes. It is the documented act of demonstrating that a procedure, process, or activity will consistently lead to the expected results.

The goal of the validation is to ensure that quality is built into the system at every step, and not just tested for at the end, as such validation activities will commonly include training on production material and operating procedures, training of people involved, and monitoring of the system while it is in production. In general, an entire process is validated and a particular object within that process is verified. The regulations also set out an expectation that the different parts of the production process are well defined and controlled, such that the results of that production will not substantially change over time.

i) It helps in obtaining minimum batch failures.
ii) Efficacy and productivity can be increased with the help of validation.
iii) It helps in the optimization of the process.
iv) Capital expenditures can be reduced.
v) Number of batches rejected can be reduced.
vi) Output can be increased.
vii) Deviations caused in the process can be investigated.
viii) In-process testing and testing of finished products can be reduced.
ix) Set up and start-up of new equipment can be done more rapidly and reliably.
x) Equipment can be maintained more easily.
xi) Automation can be done more rapidly.
xii) Failures due to process can be minimized.
xiii) Validation is necessary to obtain approval to manufacture and to introduce new products.

1.      Validation master plan (VMP)
2.      Standard operating procedures (SOPs)
3.      Quality manual
4.      Specifications
5.      Validation & Qualification protocols
6.      Validation & Qualification report