• gmp-verlag.de
  • GMP MANUAL Login
  • Shopping cart
Shopping cart
Your shopping cart is empty

Show shopping cart...


Stay informed!

If you’d like to be regularly informed of the latest developments at Good Manufacturing Practices


>>> REGISTER for our free GMP Newsletter LOGFILE

GMP Subject Downloads

Risk Management
€ 99.00
€ 117.81
  19% VAT included
established methods of risk analysis
incl. ICH Q9
122 Pages
ISBN: 978-3-943267-11-2
Excerpt from the GMP MANUAL

It is an effort to look systematically at the critical steps of a process by using established methods of risk analysis, e.g. FMEA or HACCP. With the publication of the ICH Q9 in November 2005 risk management became an intensive discussed topic worldwide. The implementation of risk management in a company promises to select between significant and less important steps and thereby reduce the efforts to an acceptable minimum.

Apart from describing content you will find many tables, examples, forms, which can be used in the daily practice.

Table of contents:

- Risk Management Process
- Risk Management and Quality Management System
- Methods of Risk Management
- Fault Tree Analysis (FTA)
- Failure Mode Effects Analysis (FMEA)
- Application example of a combined FTA an FMEA
- Hazard Analysis of Critical Control Points (HACCP)
- ICH Q9 Quality Risk Management

Full Table of Contents Risk Management.pdf

Please note the following procedure guidelines:

If you choose payment by bank transfer:

  • You will receive an advance invoice.
  • After payment is received an email with the download information will be sent.

If you choose payment by credit card:

  • Immediately after the credit card payment you will receive an email with the download information.
  • The invoice will be sent by postal mail as soon as possible.

Technical Requirements

This file is in PDF format! To view these files, you need Adobe Reader installed on your computer. If you don't, you will need to download and install it.

>>> Adobe Reader - free download

Mario Hertlein, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

with Andreas Kaßube, Dr. Thomas Linz and Frank Till
A Process Approach to Pharmaceutical Quality Systems
GMP Audit Checklist (Book)