The following article is intended to define some primary concepts in the field of process validation that, in recent years, have become increasingly essential for medical device industries in order to prove the effectiveness and safety of their products being reviewed by regulatory agencies.
We start by providing a definition of the process validation and proceed to describe the regulatory and formal aspects that offer official evidence of its importance. Afterwards we focus the attention on when to perform a process validation, explaining the characteristics that a production process must have to become eligible for it.
At the end the classical approach is illustrated, describing the three phases of a typical process validation: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
In addition, stricter documentary aspects involving the Validation Plan (VP) and Validation Report (VR) are addressed. For each phase, a guide is provided for the essential document content.