MODULE 5

Qualification of facilities, utilities and equipment: general

Aims

The aim of this module is to provide the candidate with an understanding of qualification concepts, strategies and activities, as well as the integration of Good Engineering Practice, Commissioning and Qualification in such a manner as to:

• reduce the number of tests to be performed.
• eliminate duplicate testing.
• reduce project timelines.
• ensure that documentation and information is available when required.

Learning outcomes

On completion of this module the candidate will be able to:

• describe the principles and concepts of facility, utility and equipment qualification.
• define and describe the purpose of each of the qualification activities (IQ, OQ, PQ), and how they are inter-related.
• describe the contribution of qualification activities to the Regulatory Requirements.
• list the types of documents required to develop IQ, OQ and PQ protocols.
• describe how the Master Plan, the system definition and boundaries, and impact assessment affect the qualification activities.
• develop a procedure for writing qualification protocols.
• describe the contents of each type of Qualification Protocols and to develop the protocols for a given system.
• describe the role of training, suppliers, and contractors in the qualification process.
• describe the importance of change control during the qualification process.
• describe the role of authors, reviewers and approvers for qualification documentation.
• describe the principles and concepts of GEP, FAT, SAT, and Commissioning.
• describe the relationship between commissioning and qualification, and the impact assessment.

Tutor Information

JAN E C GUSTAFSSON

Jan E. C. Gustafsson, PhD, is senior principal scientist, Quality Support, Novo Nordisk A/S, Denmark. The subject for his doctor´s dissertation was to find and analyse human proteins from different body fluids. He has over 30 years experience in management positions and has worked in 3 countries. He has experience of working within executive management groups as vice president of 4 companies during 15 years. Throughout the years, quality, development, production, biopharma and validation have been important parts of his work.

In ISPE he has been active in the European team, extended team and author of one chapter in the ISPE Baseline Guide on Commissioning and Qualification. He is one of the dual leadership of ISPE Baseline Guide “Biopharmaceuticals” and is member of the core team, and chairman of the European team. He is also member of ISPE Technical Documents Steering Committee, and has been active for a long time to create the MSc-course “Industrial Validation Science” at Dublin Institute of Technology, Ireland. During the years, he has made numerous presentations on different subjects internationally.