What is process validation and why do we do process validation?
Good manufacturing practice is an essential part of the production of human drugs, veterinary drugs, biological and biotechnology products, and pharmaceutical ingredients. These commercial processes are subject to regulatory oversight and must ensure that every aspect of the production process is carefully scrutinized. The purpose of process validation is to collect data and scientifically analyze the production process from conception to large scale production. An updated process validation protocol is essential to ensuring product quality and consistency. Many laws have been established to mandate process validation in order to protect consumers, especially in the case of pharmaceutical products.
Process validation in the pharmaceutical industry takes the same form as process validation in all other industries, but the stakes are higher because the product is made for human consumption. Moreover, pharmaceuticals are made to alter the natural biochemical pathways in the human body, so these chemicals must be formulated correctly and consistently every time. Additionally, the products must be stored properly and shipped under climate-controlled conditions in order to ensure efficacy once reaching the consumer.