Glossary
Log Deviation
What is Log deviation in pharmaceutical industry?
In the pharmaceutical industry, Log deviation typically refers to any deviation from established procedures, protocols or expected results in the manufacturing, testing, or distribution of pharmaceutical products. These deviations can impact product quality, safety, and efficacy, making it crucial to identify, document, investigate, and address them.
Log deviation is recorded instance where something gone range outside in the pharmaceutical process. This could be related to manufacturing processes, laboratory testing, equipment performance, environmental conditions, or any other aspect of pharmaceutical operations.
What are the types of deviations?
- Minor Deviations: Small variations that are significant to impact product quality, safety or efficacy.
- Major Deviations: Higher potential to affect the product and may require more extensive investigation and corrective actions.
- Critical Deviations: Pose a significant risk to product quality patient safety or regulatory compliance and require immediate investigation.
Why is Log deviation important in pharmaceutical industry?
Log deviation is crucially important in pharmaceutical industry for several key reasons:
Product Quality: Log deviations ensure that pharmaceutical products meet the required quality standards by identifying and addressing deviations can prevent the release of substandard products that could harm or be ineffective.
Regulatory Compliance: Regulatory bodies such as FDA EMA and other international agencies require strict adherence to GMP. Deviations from approved procedures and specifications must be documented, investigated and resolved to maintain regulatory compliance.
Root Cause Analysis: Log Deviations allows systematic investigation and root cause analysis. It helps in understanding the root cause of a deviation and helps implementing corrective and actions (CAPA) to avoid recurrence.
What are the different types of log deviations in pharmaceutical industry?
Types of Deviations:
- Process Deviations: Variations from standard procedures during manufacturing, such as changes in temperature.
- Analytical Deviations: These involve during testing of pharmaceutical products such as unexpected results in stability testing or deviations in assay results.
- Equipment Deviations: These involve in equipment malfunctions or performs differently from its specifications potentially impacting product quality.
- Documentation Deviations: These occur when there are errors in documentation, such as batch records or incorrect data entries.
