- Download PDF
1 Answer | Add Yours
Since you are interested in non-clinical personnel, I will talk about this from a particular non-clinical perspective: pharmaceuticals. Large pharmaceutical companies make the drugs that the patients will ultimately put into their bodies. The manufacturing of these drugs involve using chemical reagents and solvents that are not safe for human consumption. So the quality control over these manufacturing processes and the drugs they produce must be extremely detailed and thorough so that the final product is safe for human use. The manufacturing sites must be regularly inspected and approved by the FDA to begin with before the process can even begin. Once a process has been put into production, the quality control department must monitor the process every step of the way utilizing sophisticated equipment to make sure that everything is correct. Every step of the drug manufacturing process is laid out in detailed writing before it can even begin. Not even the slightest detail is overlooked. There are validated procedures and processes for even cleaning out the chemical reactors and verifying that they are clean between runs. All of this involves a large number of non-clinical personnel to plan and carry out all of these steps to ensure a clinically safe final drug compound. Engineers, lab scientists, and technicians all contribute to the process.
We’ve answered 323,597 questions. We can answer yours, too.Ask a question