The Importance Of Process Validation

In 1987 the Food and Drug Administration (FDA) established its expectations regarding process validation in the Guidance for Industry Process Validation. In this document the general principles and process validation components that are considered vital towards effective process validation are outlined. It also highlights the importance that these approaches be consistently and repeatedly used by all manufacturers through their manufacturing processes. The FDA also outlines the importance of the cohesion between process validation and other pharmaceutical regulatory systems such and Good Manufacturing Practice (GMP), Quality, compliance and the manufacturing lifecycle. Since 1987, the FDA has also produced revised guidance's building on the principles in its original document to maintain and modern and updated approach to the topic. In essence, this document highlights how controlled and effective process validation is required to maintain the highest standards of drug quality to allow the safe and repeatable production of pharmaceuticals intended for human use. If these principles h...