Corrective action and Preventive Action | CAPA in Pharmaceuticals

Definitions:

Corrective Action: Action taken to eliminate the causes of an existing non-conformity, defect or other undesirable situation in order to prevent recurrence.

Preventive Action: Action taken to eliminate the cause of a potential non-conformity, defect or other undesirable situation in order to prevent occurrence.

Handling of Corrective and Preventive action

In Pharma working quality management systems will identify non-conformities, non-compliances arising due to various causal factors and situations as follows:

-          Customer Audits

-          Regulatory audits

-          Internal Audits

-          Out of specifications (OOS)  

-          Product quality review

-          Deviations

-          Out of calibrations (OOC)

-          Customer complaints

-          Product Recalls

Such non-conformities and non-compliances should be investigated thoroughly with an aim to identify the route cause, root cause can be done as “Root cause analysis” Click to view.  In some cases root Cause may not be identified that need to be justified properly and effort for identifying the root cause should be documented.

Based on the root cause analysis Corrective and Preventive action should be identified, defined and implemented

General Principles

1.      Pharma Manufacturer Should have an written procedure for Handling of CAPA with documentation and records

2.      All Corrective and preventive action should be time defined and tracked for closure.

CAPA with Examples:

Example: 1

Situation:  A spray nozzle on a tablet coating device developed partial plugging during the coating of a batch or product xxxyyy. This resulted in unevenly coated tablets. An electrical out age in the plant delayed processing by 12hours.

Root Cause: The root cause was determined to be the use of a suspension that washed beyond the maximum holding time after preparation

Corrective action:

Modify the xxxyyy manufacturing instructions to state more clearly the need to prepare and utilize the coating suspension within the specified holding time.

Modify the equipment cleaning and setup procedures to require full nozzle disassembly after each batch.

Prevention action:

Examine spray nozzle sand suspension make up SOPs for other products onsite.

Example 2:

Situation:  Deviations of incorrectly weighed ingredient have been reported. The error was detected during routine manufacturing checks. The incorrect weight of ingredient was dispensed in the Central Dispensary

Root cause: The immediate cause is a calibration failure of the scale used to dispense the ingredient. This was caused by reference weights being cleaned and Not re-calibrated prior to use. Root cause is the absence of any procedural controls for reference weights.

Corrective action: A procedure for the handling of reference weights was developed and implemented. All reference weights were checked to an agreed plan devise d on the basis of risk to product quality.

Preventive action: Communicate/share learning’s with other sites within the network.