Validation in Pharmaceutical


Thread Starter


I am a controls engineer in the heavy industries doing basic engineering and design in control systems. Recently someone I know suggested to move over to validation in pharmaceutical industry. I am confused on the issue in terms of choice of industry (heavy and pharma) and in terms of the work (basic engineering and design to validation). Some people think validation to be non-technical (is it so?). Any comments as a help to clear the confusion or add to it?

david mertens

In short, validation is the implementation of a quality system approved by the FDA. It is designed to ensure that every part of a pharmaceutical installation meets the standards during every stage of its life-cycle (design, construction, startup, production, maintenance and decomissioning). Keywords are good practices and tracebility. It is a very large field and some parts of it may not require much technical knowledge. However, if you have to prove that a certain program in a controller will act in certain ways, it may be usefull to at least know how these things work in order to design a testing procedure to prove (validate) that this is true. Validation is always teamwork, as mechanical, electrical, chemical, pharmaceutical and software engineers each have to help the validation officer with all the necessary documentation and testing. So the only person that's not really a technical specialist is the validation officer. However to be succesfull, he must have a broad knowledge of technical stuff without real specialised knowledge in a specific field and have good administrative skills as well. His task is the interfacing between the technical staff and the FDA and he is responsible for the final FDA approval of the entire project.
Personally, I find validation boring. But there are some people that enjoy it. I work in the pharmaceutical industry on the development side. We usually worry about making instruments that satisfy UL and CE requirements more than anything else. I suppose validation can get technical. But I assume that it is a lot of research and
writing, and not a lot of engineering.

You might check out 21-CFR-Part 11 regulations. It has become the FDA standard for pharma industry.


Valley Dater

While MANY people may find the role of validation as being boring, it depends up how creative you are and how able you are to understand regulations, standards and specifications and how to apply them to your subject area to ensure compliance. I have been in the IT world for over 26 years and started out as a mainframe programmer and went on to perform every duty on the SDLC (programmer, leader, technical writer, tester, system architect, etc. etc.). I find that if you yearn for knowledge, that this is the industry to be in. While I wish I had more sciences (chemistry, biologics, etc.) I find that I am always learning because a validator must (or I will say 'should') know everything they can about the equipment they are validating. This brings you into your job being almost a fulltime class... and I love it.

Then again... I am the kind of guy who owns hundreds of non-fiction books and maybe 1 or 2 fiction.

Take this for what it is worth.