Verification proceeds validation, but it does not replace it. In this part of the manufacturing or research process, equipment, products, production methods or programs must be repeatedly tested. This proves they are reliable. Though there will always be a margin for error included in any calculations, after doing the verification stage you can say youâve completed this side of pharmaceutical quality assurance to the best of your ability.
That means you will look into not only how it was put together and assembled, but also the people operating it and the conditions it is operating under. In medical manufacturing, whether it is pills or prosthetics, nothing may be left up to chance. That might mean strict temperature and humidity regulation or meticulous logging of the body motions of staff when they do a task.
Once everything has been verified, you may use the data to validate it. Validation looks more at the end product, basically making sure that the same thing results every time the process you verified is followed. In drug testing or even food safety certificate, this will involve everything from weighing samples to mandatory mechanical tests of permeability and chemical composition.
In both cases, who does what may change the term that applies. For example, regardless of who does what, pharmaceutical quality assurance requires four processes in regards to the tools you use:
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)