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Qualification and Validation: Agency Expectations

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A qualification serves to prove that equipment is fit for its given purpose. So far, so good. But what are the actual fundamental requirements for a successful equipment qualification and what are the core elements of qualification work?

e-book

57 Seiten

ISBN: 978-3-95807-098-1

1st edition 2018

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Techn. Voraussetzungen

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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

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Persons who are responsible for the qualification and validation in the areas of quality management, quality assurance, quality control and production
External service providers who support qualification and validation
Suppliers of facilities and equipment
Persons who are responsible for qualification and validation documents

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Technical Requirements

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