Ways out of the validation jungle
Validation from a process equipment manufacturer’s point of view

In the pharmaceuticals industry, machinery and systems need to be validated. So far, so good. While it is true that there are numerous recommendations, instructions, and guidelines, putting these into practice is frequently a painstaking and expensive effort. A Validation Master Plan developed in good time is indispensable for both sides to control costs.
I In the pharmaceuticals industry, the qualification and validation of systems, plant, and apparatus is common practice. Business enterprises intending to design and operate a manufacturing facility and to sell their products on the US market, will inevitably be subject to supervision by the FDA (the Food and Drug Administration). Essentially, the objective is to ensure that a machine or system produces a product with a level of quality that remains constant, and, in particular, that documentary evidence of this is available. The main expenditure incurred in the validation or qualification of a piece of equipment or apparatus results primarily from implementation in terms of electrical engineering and there, particularly, from providing documentation relating to computer-assisted process instrumentation and control engineering. Therefore, the sections below will focus on the qualification and documentation of computer-based systems and apparatus.