Deviation is defined as any departure from an approved instruction or established standard. It requires evaluating, investigation, response and control.
Following are types of deviations:
Deviations from all departments
OOS From labs
OOT (Raw materials, Components, Containers & Closures, API, Finished products)
It is implemented by CAPA approach.Normally a closed loop approach.
•Identification of problem
•Evaluation and data gathering
•RCA (Root cause analysis)
•Development of action plan
•Implementation of CA
•Verification of effectiveness
•Implementation of PA