Definition:
Deviation is a departure from approved procedure or specification.
A deviation is an activity performed differently and/or modified than that specified in an approved document.
There are two types of deviations
1) Planned Deviation.
2) Unplanned Deviation.
1) Planned Deviation -
Planned deviations, which are described, and pre-approved deviation from the current operational document/system, covering a specified period of time or number of batches.
Planned deviation shall be approved before execution
2) Unplanned Deviation -
Unplanned deviations also called as incident.
Incident can be defined as unplanned or uncontrolledevent in the form of non-compliance from the designed systems or procedures at any stage of manufacturing, packaging, testing, holding and storage of drug product due to system failure or equipment breakdown or manual error.
Deviation is a departure from approved procedure or specification.
A deviation is an activity performed differently and/or modified than that specified in an approved document.
There are two types of deviations
1) Planned Deviation.
2) Unplanned Deviation.
1) Planned Deviation -
Planned deviations, which are described, and pre-approved deviation from the current operational document/system, covering a specified period of time or number of batches.
Planned deviation shall be approved before execution
2) Unplanned Deviation -
Unplanned deviations also called as incident.
Incident can be defined as unplanned or uncontrolledevent in the form of non-compliance from the designed systems or procedures at any stage of manufacturing, packaging, testing, holding and storage of drug product due to system failure or equipment breakdown or manual error.
No comments:
Post a Comment