Every pharmaceutical manufacturer must have and implement suitable processes for dealing with deviations from processes and quality specifications in order to continuously ensure the required quality of the products.
There are many reasons for deviations. They range from quality problems in the raw materials, materials, equipment and devices used to inadequate description or implementation of the manufacturing, testing and quality assurance processes.
A wide variety of reasons can lead to a backlog in the processing of deviations or deviation management.
The workload associated with the processing of deviations and the associated commitment of personnel resources across all areas of the quality system can even become so great that batch-relevant deviations are not processed in time and these are not sufficiently taken into account for the release of the product batches.
Regulatory authorities therefore regularly review the status and implementation of deviation management by pharmaceutical manufacturers in their inspections.
For the regulatory authorities, the status of deviation processing, in particular the handling of critical deviations, is an essential indicator of whether the pharmaceutical quality system is functioning.
Therefore, inspectors regularly check the lists of deviations from the current year and also from previous years with regard to the processing of the deviations.
In this context, it is also checked whether the root causes for the deviations have been correctly determined and suitable CAPAs (corrective and preventive measures) have been defined and implemented, in order to reduce or prevent the recurrence of the deviations.
How to gain control of your deviation management?
A review of the status of deviation processing indicates whether the associated processes are working and under control. However, a review of the lists of deviations alone is not sufficient for this.
It must not only be checked that the list is up-to-date with regard to recently occurring deviations, but also that deviations that occurred in the previous manufacturing period have been completely recorded and processed and completed in accordance with the regulatory and internal company requirements.
Related: Deviations Management: From Root Cause to Resolution
Resource Person: BARBARA PIROLA
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