Know How - Design Pharmaceutical Qualification Processes Efficiently

An interview with GMP expert Ralf Gengenbach, gempex GmbH 

The question of whether pharmacists implement GMP compliant qualification of production facilities or the validation of associated processes no longer arises today - rather the question is how the effort can be kept as efficient (low) as possible in order to ensure GMP compliant product quality and stay productive at the same time. Read in the interview with GMP expert Ralf Gengenbach, Managing Director of gempex GmbH, where there is room for optimization in qualification.

Mr. Gengenbach, what does the concept of qualification according to the GMP guidelines mean?

Qualification is a sub-topic of Good Manufacturing Practice (GMP) and is mainly used for pharmaceutical quality assurance. This is documented evidence that a technical system meets all of its requirements and provides the required performance.

If you say that the qualification already exists according to the definition, are there still difficulties in understanding the implementation of the qualification?

Yes - The problem is that the subject of qualification is often confused with the checking and testing of a technical system. A qualification is documented evidence of a desired condition and is not a test of a system, device or software. 

Ralf Gengenbach, gempex GmbH

It means that the qualification only begins after successful testing – ideally, when all errors in the engineering area have been fixed.

Why is there room for interpreting the specifications and implementing them?

Good Manufacturing Practice provides general guidelines and not detailed standards as to what to look out for in an individual system. The field of devices, systems and technologies that are used in the pharmaceutical industry is so broad that there cannot be a standard for every technical system.

What do you see as the greatest challenge in terms of qualification - especially when errors occur?

If the qualification is purely an obligation to provide evidence, then the prerequisite for this is a high-quality, technical product. If errors from Good Engineering Practice (GEP) creep in during qualification, the qualification process becomes very complex and many times more expensive than if the errors were discovered and eliminated as part of the GEP. 

The bottom line: The worse the engineering process is, i.e. there is no Good Engineering Practice, the more complex the qualification process becomes. The key to efficient qualification is therefore a good engineering.

Many project partners come into play when implementing a validation and qualification project: How can suppliers and pharmaceutical manufacturers work together successfully in order to meet the high requirements efficiently?

There are intensive efforts to harmonize the interaction between suppliers, engineering and pharmaceutical manufacturers. This starts early with the planning and becomes particularly important in the so-called EPC (Engineering, Procurement and Construction) and commissioning phase. There is a guideline that gives recommendations on communication channels, project schedules and the distribution of tasks between the partners involved, particularly with regard to qualification. There are many points to consider that go far beyond the topic of qualification, so that the cooperation between all parties involved goes hand in hand over the long term or on a project basis.

Read the whole interview here.