Several friends have asked what is it that I actually do for a living in engineering. It’s not a “normal” engineering job, it’s definitely niche. I straddle the line between engineering and law, in a field known as Validation.
Per Wikipedia, “Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages.” In short, it’s the objective evidence that everything that goes into a consumable product plays nice by the laws of the country in which it is sold. In the USA, those laws are several key sections of the FDA Code of Federal Regulations (CFR).
It’s a complex job that requires knowledge of all engineering disciplines, plus law, plus effective written communication to accurately document through testing protocols and reports the objective evidence obtained. I never know if I will be spending the day on my feet in steel toes, in a clean room all gowned up for containment, at my desk writing, or running around chasing information. The job is challenging enough to keep my interest, as I work from project to project.
Let’s take a common item, like ibuprofen. How do you know that the ibuprofen you’re taking is safe to use? Or that it’s the right dosage? Or that it’s actually ibuprofen and not something else? You, the consumer, probably don’t think about it too much. That’s because its safety, identity, strength, purity, and quality (aka SISPQ) are ensured by 21 CFR 210.1(a). Everything that goes into its production has been tested and proven to be in compliance with the law before the product is released.
What does that really mean? Well, think about how the drug has to be made. The active ingredient is compounded in a reactor. Everything that goes into that reaction has been verified for SISPQ. That means the water and everything it touches, the air and everything it touches, the reactants, and the reactor itself have been tested and verified with objective evidence that they are safe to use. The reaction itself has been verified through assay at multiple points within the reaction to ensure that everything is going smoothly and that we end up with raw ibuprofen at the end. The active ingredient then has to be compounded with the inactive ingredients, to result in an even distribution of the ibuprofen so that each tablet will be approximately 200mg. The compounding mill has to be tested for safe contact surfaces and for operation. Then the milling process has to be tested and verified that it will reliably distribute the active ingredient within the inactive ingredients.
So now we have powdered ibuprofen at the desired concentration. Next it has to be compressed into tablets. The tabletting machine has to be tested for safe product contact surfaces and for safe operations, and then the tabletting process has to be tested and verified for reliability. See a pattern yet?
Next the tablets have to be packaged in bottles. The bottles have to get 100 tablets, a plug of cotton, a seal, a cap, and a label, then packaged in a carton. This is typically accomplished by an integrated packaging line of multiple pieces of equipment. Each piece of equipment has to be tested for, again product contact surfaces, operations, and reliability, AND the whole line has to be tested together to ensure that all of the equipment can work in sync. These integrated lines are also typically automated with custom coding, which also has to be tested.
Finally, the cartons have to be packaged up in cases, and serialized/aggregated to the cases. This means that each carton containing a bottle has a unique serial number, and that serial number is aligned with the serial number on the case. Therefore, we can determine what lot of ibuprofen was in which case, which was shipped to which store, and where. This is important in the event that something goes wrong with any of the failsafes built into this system, and a product recall is required.
On top of all of this, the rooms/buildings in which all of these activities take place must be tested and verified to be in compliance with laws and guidance, the climate control in the rooms/buildings must be tested and verified, and the computer system which controls the climate control must be tested and verified. The compressed air must be verified as “clean” (that is, no humidity, oils from the compressor, or bioburden) and its supply system must be tested.
It’s a lot to think about, it’s a lot to test, it’s a lot to verify, it’s a lot to document. Companies have entire libraries dedicated to hard copies of validation documentation, and entire servers dedicated to the electronic storage of soft copies. It’s all in the name of product SISPQ, and proving that the product is safe to consume. You can think about me the next time you reach for that bottle of ibuprofen.
