Deviation in the quality management of pharmaceutical companies represents a discrepancy between the planned and actual conditions or results within a regulated process.
Deviation and deviation management in the following areas:
- Risk management: Deviations are indicators of potential quality or safety problems. They help to identify and minimise risks before they affect product quality or patient safety.
- Compliance: The management of deviations is crucial to ensure that processes comply with regulatory requirements. Regulatory authorities such as the FDA or EMA require companies to document deviations and take appropriate measures.
- Continuous improvement: By analysing deviations, companies can identify causes and optimise processes to avoid similar problems in the future.
Exemplary application areas of deviation management
- Production processes: Deviations occur when production parameters are outside the specified limits, such as temperature or pressure deviations during production.
- Quality control: Deviations can occur in the form of test results that fall outside the acceptance criteria.
- Material and supplier management: Differences in the quality of raw materials or components can also be regarded as deviations.
- Documentation processes: Errors or incompleteness in the documentation are also deviations and must be corrected to ensure data integrity.
