Quality management

Risk analysis

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 SOPs but can also bring our own established 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 on the basis of rationally justified factors that may have an influence on product safety need to be qualified or

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 this? The list of, mostly minor, deviations is getting longer and longer but you just don't get around to working on these or don't have the human resources to process and close these deviations according to requirements. 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 employees can provide effective support in this area 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 Guide. It is the interplay 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 has been providing training in GMP quality management himself 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. Here we often see long lists of good measures. The implementation of these mostly stalls because of capacity reasons. This not only increases the risk that deviations will occur again, but usually also takes away good opportunities for process optimization.

Here, too, our trained quality engineers can help. They take care of their CAPA lists and consistently follow the measures described therein until the measure is completed and the necessary success control is carried out.