Risk Analysis

So that everything works the way it should

GMP risk analyses are key for successful inspections by the authorities – at the latest since the FDA established the “Risk-Based Approach”. By means of systematic analysis, the risks in processes and production facilities can be determined, assessed and reduced by defining appropriate actions.

A question of method

The basis for a beneficial risk analysis is the selection of an appropriate method. The “Failure Mode and Effects Analysis” (FMEA) has proven very efficient. Chemgineering makes use of it in slightly adapted form. In so doing, we highlight critical GMP aspects of processes and equipment and define a comprehensible rationale for the scope of validation and qualification.

Our offering reduces your risk

In particular, you can count on the following services:
• Defining the appropriate method
• Structured working out and description of risk cases
• Conducting risk analysis: assessing the risk cases jointly with operators, quality assurance, engineering
• Documentation of the results
• Training sessions

You’re wondering where to start? We would be happy to determine the appropriate method for you and provide you with an overview of your qualification risks.

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Chemgineering Business Design AG | Binningerstrasse 2 | 4142 Münchenstein | T +41 61 467 89 00 | F +41 61 467 89 01 | www.chemgineering.com | info@chemgineering.com