Qualification: V- Model Approach, Qualification Matrix, Qualification Activity

-

Qualification is documented evidence that a specific equipment, facility or system is fit/ready for intended use. It is further divided into DQ, IQ, OQ & PQ.


1. Qualification : V-Model Approach

V- Model Approach: It is called the V-model because of its characteristic “V” shape. The left arm of the “V” represents the planning / specification phases such as User Requirements Specification, Functional Specification, Detailed Design, and the right arm of the “V” represents the execution-validation phases such as Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) and both the arms converge at the Build and Unit Testing phases at the V-Point.

2. Qualification Matrix

Qualification Matrix: Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results. 

3. Qualification Activity Matrix

Qualification is documented evidence that a specific equipment, facility or system is fit/ready for intended use. 

For any feedback or suggestions write to us at info@pharmastate.com

PharmaState Blog
This is a platform for people working in the pharmaceuticals industry for Discussions, Jobs, News updates, Professional Profile display space and company business pages. PharmaState DNA is having four pillars: Quality, Transparency, Innovation & Benchmarks.

Share this article

Recent posts

Popular categories

1 COMMENT

Leave a Reply

Recent comments

Business Alnavedic on History of Indian Pharma Industry
Ahmed Mohamed Elkhodragy on MACO Calculation
Jennifer Osunde on DEFECTS IN UNCOATED TABLETS
Vinod on DEVIATION
Sunil Kumar M on SITE ACCEPTANCE TEST (SAT)
Khalid on IQ Protocol
Khalid on IQ Protocol
Nagabooshanam on Calibration of Reactor
PharmaState Blog on SOP for Sampling
Swapnil Khodake on TOOLING FOR TABLETING
%d bloggers like this: