The following should be checked during the investigation:
After the investigation, the following should be carried out:
It must first of all be clarified whether the deviation was caused by a lack of production hygiene or whether an error was made in the laboratory.
If an error was not made in the laboratory, the effect of the deviation on the product quality is extremely important. Deviations in the personnel lock, for example, are generally not relevant to the medicinal product. If a deviation does affect the medicinal product, the product should be placed in quarantine. If the deviation is relevant to the medicinal product, testing must also be carried out to clarify whether the product quality is in fact being negatively affected.
The PDA Technical Report 13 (Revised): Fundamentals of an Environmental Monitoring Program (2014) contains a useful summary of actions to be taken when deviations occur (see Figure 1). Although it applies primarily to sterile working environments, the approach taken can also be used in facilities where non-sterile preparations are manufactured and filled.
Figure 1: Corrective actions if levels are exceeded (PDA 2014)
It also makes sense to create a checklist for detecting the causes of errors as suggested by Gingsbury1 to ensure that nothing is forgotten during the process.
If necessary, additional testing should be carried out to discover the source of the microorganisms. If the action level is exceeded, the microorganisms definitely need to be identified. This normally provides information about the source of the microorganisms. When the corrective actions have been taken, appropriate examinations should be carried out to show that the actions taken have been successful and the area and/or process is once again under control.
When the investigation has been completed, an investigation report must be created that documents the following: