What is process validation for drug / pharmaceutical products?

What is Process Validation?

The FDA defines process validation as, “the collection and evaluation of data, from the process design stage through marketable product, which establishes scientific substantiation that a process is able of constantly delivering quality product”.

A foundational tenet of this FDA guidance document is the lifecycle conception. The lifecycle approach is concerned not only with the original drug development processes; but also, the establishment of marketable manufacturing and routine marketable product until discontinuation of the product.

Process Validation is conducted to ensure consistent delivery of quality products meeting its predetermined specifications/requirements and quality characteristics. This enables to ensure the complete safety & efficacy of medical device.

IZiel works with your team to assist you to complete all the following process validation activities for your medical devices.

·         Process Validation Master Plan (PVMP)

·         Process Characterization

·         Equipment Installation and Qualification (IQ)

·         Operational Qualification (OQ) – 

·         Performance Qualification (PQ)

·         Test Method Development (TMD) & Validation (TMV)