What is a Deviation in pharmaceuticals?
Managing deviations is one of the most important aspects of pharmaceutical manufacturing. Defining deviation as a departure from written instructions, if there are no written instructions, deviance is anything that happens without being intentional, for instance, spilled material, use of incorrect materials during dispensing, using old or outdated documents.
Nonconformity/noncompliance with written procedures in the quality system of an organization is called as Deviation.
Measurements that differ from normal or expected values occur when they occur in different parts of a process or product. They also occur when they differ from procedures or standards.
Types of Deviations in pharma:
There are two types of deviations in pharma:
- Planned Deviation
- Unplanned Deviation
1. Planned Deviation: Intentional or deliberate nonconformances or deviations.
2. Unplanned Deviation: The observation or documentation of an incident, non-conformance, or deviation obtained accidentally or unanticipatedly during, or after an activity has been executed.
Hope you understand what is a deviation in pharmaceuticals.
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