The pharmaceutical industry invests significant sums of money, research time and effort to develop a product to the point where it can actually take a drug to the marketplace. The pharmaceutical company has to market and sell the product in order to recover all of the research and development costs within the protection period given by the various patents which are in force. In a lot of cases the company will not be able to make much profit after this period, as competitors can often, and will, clone the technology used for a fraction of the original investment. It is of paramount importance to have equipment which is reliable and can produce the required product volumes for the market, as quickly and reliably as possible. In the modern pharmaceutical arena speed to market, profits and lower overheads are essential competitive imperatives. The elements of Good Pharmaceutical Engineering Practice will start at the design stage where the plant has to be designed to facilitate the realisation of the quality objectives and achievements of the standards laid down by the Good Manufacturing Practice (GMP). The overall philosophy in any modern design is the principle that the quality of a pharmaceutical product has to be built in and cannot be inspected in. Validation is a tool developed to ensure that the equipment is reliable. This paper describes the principles of validation and how it can be applied in an industrial scenario. It discusses qualification techniques and offers a case study into how the validation principle is applied to a project.
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