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
VMP facilitates the work process of:
Validation Team Members
Management
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.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.
