THOMAS CRAGNOLINI
Associate Director CVQ, CSL Behring, Switzerland

Abstract

A risk-based approach in commissioning and qualification has definitely benefits compared to the traditional approach. Though it is a challenge to transition from a traditional to a risk-based approach. Taking the necessary steps to implement a risk-based approach can help to focus on the essential parts of an installation, e.g. those parts that need to be under control as they may affect patient safety. For a successful implementation of this still untraditional approach it requires implementing a different mind-set (or maybe even a paradigm change) in the stakeholders, a re-consideration from the beginning of the design setup to ensure that good engineering practice is applied throughout the design and construction process allowing quality functions to develop confidence that not every nut and bolt needs to be qualified.

The concept of a risk-based approach in commissioning and qualification is not new, it goes back to the early years of 2000 when the concept was published the first time. In the meantime, the ASTM E2500 has been issued, followed by some other guidelines like “ISPE Good Practice Guide applied risk management for commissioning and qualification”, or “ISPE Guide Risk Based Approach Facility Delivery”, just to name a couple.

This paper will investigate on how this new concept and related regulatory and guideline documents can be implemented. It shall show how many risk assessments can be used to perform a commissioning & verification approach that ensures that product is safe for the patient. The purpose of equipment commissioning, qualification, process validation and cleaning validation is to demonstrate operational control and integrity of dosage preparation, thereby assuring a safe product for the patient.

The purpose of equipment commissioning, qualification, process validation and cleaning validation is to demonstrate operational control and integrity of dosage preparation, thereby assuring the health of the patient.< ...