Qualification and Validation: Agency Expectations

Excerpt from the GMP Compliance Adviser

The ultimate prerequisites for GMP-conform pharmaceutical manufacturing are validated processes and qualified equipment! Qualification and validation should prove that the equipment, the procedures and processes used during the manufacture of medicinal products are suitable for their purpose. Previously defined acceptance criteria for the critical quality attributes and process parameters have to be met reproducibly.

This sounds plausible. However, the practical implementation raises many questions. How do you correctly use risk management? By what means can the life cycle concept be realised? How do you organise planning, performance and documentation efficiently and in a GMP-conform manner? And most important of all, what are the expectations of the responsible authorities?

In this report Michael Hiob provides all the answers. It is a “must have” guidance for all those who are involved in qualification and validation

You'll learn in detail about:

• The Regulatory requirements for qualification and validation
• Risk management and life cycle concepts
• Organisation and responsibilities
• Performance and documentation