Thursday, August 22, 2013

Verification and Validation in Pharmaceutical Quality Assurance

If you’re studying pharmaceutical quality assurance, you’ve probably encountered the concept of validation and verification. Though both are essential for drug manufacturing or any good quality management system, it is vital not to confuse the two terms. One refers to being sure that the end product is what is expected with a particular process, while the other focuses on if the process is being done correctly. They are a key focus in a pharmaceutical quality control diploma and understanding them is crucial to your education.
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 you’ve 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)
While the latter three are usually subject to verification and validation by the manufacturer, DQ is generally handled by the vendor, a separate entity. In that case it is verification. If they don’t, then in the manufacturer’s hands, the process of quality control becomes validation. This may seem complicated, but keep in mind that for example, a pill cutting machine, is the product of a separate manufacturing process. Ideally verification and validation runs all the way to the raw materials that went into the equipment and product. This is not excessive, because trace contamination is impossible to control for. Imagine the metal bolts that hold a machine to the factory floor.  If one particular batch of steel has less tensile strength than another, small irregularities will enter the process. Maybe one machine will be less steady than another, and make more errors leading to lopsided drug dosages. It’s no wonder pharmaceutical quality control students devote so much time to the subject!

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