Elite Institute of Pharmacy Skills (EIPS)

Carving Global Pharma Professionals
AN ISO 9001: 2015


Healthcare sector is too specialized area to deal with in terms of savings life of patients. Quality is the prime aim for any industry but Pharmaceutical industry exists on the best quality if intended towards catering authentic service to the society.

People depend solely on the doctor’s perfect diagnosis and correct prescription of effective drug to heal and cure. So,

pharmaceutical area of work has to be extremely perfect and need proper check and proof system of validation to build credibility. Validation, sort of establishes documentary evidence that any procedure involved in the pharmaceutical maintains the opted level of compliance. It is essential at all stages of activity chain in pharmaceutical. Relying on the processes of validation is increasing with time that directly speaks of quality in Pharmacy industry. The concept of validation was first spoken of by Ted Byers and Bud Loftus. They both were Food and Drug administration officials.

US FDA defines validation as:

“Process validation is establishing documented evidence which provides a high degree of assurance that a specified process will consistently produce a product meeting its pre- determined specifications and quality characteristics.”

Government Regulation

Validation is the integral part of GMP. It is necessary to meet the worldwide compliance with the requirements of validation to attain the goal of approval for manufacture and introduction of new products.

Importance of Validation could be summarized as

Quality assurance

Improved productivity with efficiency observing minimal failures

Process of optimization

Reliable and new equipments to be initiated

To reduce quality cost

Rapid automation expected

Time stipulation

Complaints should be reduces about processes involved

Less rejections

Maintenance of equipments should be easier

The main reason for the need of validation is to ensure highest degree of assurance is obtained for the product to be implemented. It is only possible if there is a effective designed system that assures every step of the evaluation process before implementation.

Validation Master Plan is required to describe about when the validation program would be carried and following which process. It consists of:; Prospective validation, Retrospective validation, Concurrent validation, Revalidation, Change Control.

VMP facilitates the work process of:

Validation Team Members


GMP Inspectors

Project Leaders

Validation team members are the ones responsible for:

1. Enable and ensure the compliance with the organization VMP and project validation plan.
2. They maintain and create updates as well as the approval of the validation deliverables.
3. VMP elements are verified and implemented by them.
4. Carry out consultation on evaluates and also approve changes.
5. Test review and recommendation are done by them.
6. Risk assessment.

Risk Assessment

In the area drug manufacturing and management validation is a keyword to quality production. In the process carried on for monitoring, testing and sampling it paves the way for cost reduction. Therefore it acts as a pivotal tool for pharmaceutical industry regarding the mission to deliver the end product without compromise. There is a great job prospect for the validation and documentation trained professionals in this recent flourishing pharmaceutical industry scenario of global platform.