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GMP Subject Downloads

€ 179.00
€ 213.01
  19% VAT included
Official requirements | material flow | personnel flow and layout | room classes | construction elements | barrier systems and isolators | and much more...
178 Pages
ISBN: 978-3-943267-12-9
Excerpt from the GMP MANUAL

You will find answers to these and more questions:

Which official requirements must be observed when designing rooms in accordance
with the EU GMP Guide and the U.S. cGMP regulations?

Which design concepts does FDA recommend for an aseptic processing facility?

How can the requirements for the different room grades be met?

What details must be observed when designing rooms for pharmaceutical purposes?

What has to be taken into account during installation of building services in clean rooms?

Which physical and microbiological parameters require monitoring?

Table of contents

- Official Requirements
- Material flow, personnel flow and layout
- Room classes
- Construction elements
- Barrier systems and isolators
- Building services
- Heating Ventilation Air Conditioning (HVAC)
- Process Gases
- Qualification of premises and airconditioning systems
- Monitoring of HVAC systems
- Refernces

Please note the following procedure guidelines:

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  • The invoice will be sent by postal mail as soon as possible.

Technical Requirements

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Dr. Ralph Gomez, Consultant, USA
Dr. Michael Hiob, Ministry for Health of Land Schleswig-Holstein, Germany
Dr. Hans H. Schicht, Consultant, Switzerland
Dr. Thomas Schreiner, Fresenius Kabi, Germany
Uwe Schwarzat, Boehringer Ingelheim Pharma, Germany
Benno Weckerle, Boehringer Ingelheim Pharma, Germany
Containment & Hygienic Design
Pharmaceutical Water
GMP Audit Checklist (Download)