Before going into detail first of all let us check it out what is Validation? Now here Validation is defines as"Validation is one type of documented evidence which provides the high degree of assurance that specific processes which are used will consistently produce a product meeting its predetermined specification and quality attributes"
Now The drug which is manufactured for the use of human and animals needs to be validated. The drug before releasing into the market needs to be validated by the regulatory inspector.
What is to be validated? So the answer is the entire process from the starting of the raw material till the release of final product is to be validated. It is also known as process validation.
The manufacturer of the drug is responsible for the process validation in the pharmaceutical industry. And the regulatory bodies such as FDA (Food and Drug Administration) are responsible for granting approval for the intended use by humans and animals.
Types of Validation:
- Prospective Validation
- Concurrent Validation
- Retrospective Validation
- Revalidation
In prospective Validation the process for a new formula or for a new facility is validated before pharmaceutical commences. Pre planned and scientific investigation.
Concurrent validation is done during actual implementation of a process.
Retrospective validation for already validated processes. It is the process of verifying already generated data.
Revalidation is carried out at regular interval of time.It is associated with all three Prospective validation, Concurrent validation and Retrospective Validation.
Elements of Validation are : Design qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) ie,. IQ OQ PQ DQ
Importance of Validation:
- For the assurance of Quality
- Optimization of process.
- Reduction of cost.
- Increases output.
- Easier to maintenance of equipment.
- Improved efficiency and productivity.
I hope you might have got some of the idea about validation in pharmaceutical industry to know more please visit Library @ Pharmastuff4u