Principles

 

The verification of compliance with the requirements from drug law, the GMP rules and regulations and other normative requirements is the task and obligation of all those involved in the manufacturing, analysis and distribution of drug products, including the supervisory authorities.

Inspections are one way of checking compliance with requirements, while in-process controls and quality controls are another. Qualifications check the suitability of facilities, while validations check the suitability of procedures. Common to all methods of verification and analysis is that they can only prove if a requirement is fulfilled or not. In the same way that quality controls cannot be used to check the quality right inside a product, inspections themselves cannot guarantee that the inspected area actually fulfils the requirements made of it. They can prove that a unit works in the way it is intended to, ascertain deviations and illustrate possibilities for correction. They can check if internal requirements are at all suitable to achieve an intended objective and thus contribute to the continuous improvement of a company. Inspections must therefore be considered as one of several necessary elements of a quality assurance system.

Inspections are snapshots that reveal the actual status of an inspected area at a specific time. The level of information gained from the inspection and the evaluative conclusions that can be drawn from this information depend greatly on the qualification of the inspector and on the organisation of the inspection. In spite of this, inspections can often only be carried out on random samples. This applies in particular for checking the GMP-related documents. The result of the inspection therefore usually only allows a limited evaluation for a specific area and period of time. Careful inspection planning that takes into account all operating areas over an appropriate period of time, is therefore essential.

Like other internal procedures, the inspection procedure must also be established in advance, regardless of whether or not it is a self-inspection or an inspection of third parties. In particular, the requirements that are to be reviewed in the context of the inspection must be described accurately in advance.

Even companies that have qualified their rooms and facilities properly and have validated their procedures, and which have qualified personnel and a functioning change control program, cannot rule out faults. Inspections can reveal such faults. However, it is not their main task to search for faults and especially not for the persons to blame. If the staff have an awareness of what the quality of their work means and how they themselves can contribute to the quality being "built in" to the product, they will not consider inspections as bothersome monitoring, but as a possibility and opportunity to further optimise existing processes.