Risk analyses

We perform risk analyses in accordance with ICH Q9 as part of the planning of qualifications and validations. In doing so, we adhere to the specifications from your SOP's, but we can also bring our own tried and tested templates. The most common method for this is an FMEA, often in combination with other types of risk analysis (e.g. cause-effect diagram, HACCP). We offer solutions tailored to your needs and always keep a sense of proportion in all activities: Only those plant or process parameters determined according to rationally justified factors that may have an influence on product safety must also be qualified or validated accordingly. This saves potential additional expense for unnecessary tests later on.

Qualification

Based on the results of the risk analysis, we carry out all the tasks required in the context of a qualification on your behalf. Ideally, we can avoid duplication of work and costs by referring to GMP-compliant documented tests, e.g. from previous commissioning tests.

This includes the planning, execution and reporting of the four qualification phases:

• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)

In addition, we also offer to prepare the required qualification master plans for your operation.

Do you know it? The list of deviations, usually minor, gets longer and longer, but you just don't get around to it or don't have the human resources to process and close these deviations as required. And some discrepancies have already exceeded the 30-day processing deadline....

It happens in the best of families! But the condition should not last too long, otherwise the authority will not look at it any longer either.

Our experienced staff can provide effective support here and consistently process the open deviations, including suggestions for effective and sustainable CAPA measures.

You don't become a GMP consultant by reading through the GMP guidelines. It is the interaction of extensive practical experience, knowledge of regulatory requirements and the skilful transfer of this knowledge to the individual tasks of the customer. Our team has extensive experience in the production of solid dosage forms as well as in aseptic production and biopharmacy. All employees are trained according to current standards and have a wide range of specialist knowledge. This provides you with high-quality solutions for your production process.

Detlef Behrens himself has been providing training in GMP quality management for many years, also as a lecturer at three Hessian universities and at many seminars and other training events.

Where there are deviations, there are CAPAs. And here, too, we often see long lists of good measures, but whose implementation unfortunately stalls for capacity reasons. This not only increases the risk of deviations occurring again, but usually also takes away good opportunities for process optimization.

Here, too, our trained quality engineers can help. They take care of your CAPA lists and follow up the measures described in them consistently until the measure is completed and the required success control is carried out.