1. 1. What is CAPA & why CAPA taken :

Corrective Action:                                                  

An action taken to eliminate the cause of the existing deviation, incident or problem in order to prevent its reoccurrence (occurring again).

Corrective Action shall be taken after the event

Preventive Action:

An action taken to eliminate the cause of potential deviation, incident or problem in order to prevent its occurrence (an incident or event).

stop the incident from happening (before event)

CAPA is taken to correct or rectify the problem or incident or deviation or event etc.

  1. 2. CAPA can be routed from which activities :

Corrective Action and Preventive Action can be routed or generated from the following activities (But not Limited To) :

  1. Deviation
  2. Customer and Regulatory Audits at the site
  3. Critical equipment / instrument breakdown
  4. Customer/ Regulatory complaints or Market Complaints
  5. Product recalls and Repeated failures of the systems
  6. Vendor audits
  7. Self Inspection at site (whether Internal or Corporate Quality Assurance)
  8. Rejections of the material (Raw materials, Packing materials and Finished Product)
  9. Annual Product Quality Reviews
  10. Out of Specification, Out of Trend, Incidents
  11. Mock exercises e.g. recall, safety mock drill, etc

 

  1. 3. Who will identify the CAPA & fill the form:

Based on the investigation report the Head of impacted department or the Investigation team shall identify and propose the CAPA to address the incident occurred and avoid its reoccurrence

The responsible department Head/Designee shall fill the CAPA form and send the CAPA form to QA.

  1. 4. Who shall approve CAPA :

CAPA shall be Approved by Head QA/Designee.                        

  1. 5. When CAPA shall be closed:

Authorized persons from QA shall monitor the CAPA for its completion.

On Completion of required actions the department head (imparted department) shall certify that proposed CAPA is completed and implemented.

QA shall verify the implementation and completion of CAPA by review of supporting documents and certify the same.

Based upon the CAPA the required changes done shall be shared to the user and other impacting department and required training shall be imparted.

  1. 6. What is the Target completion date (TCD) of CAPA closing:

CAPA shall be completed and closed within the Target Completion date (TCD) and if not completed within the TCD can be revised with appropriate justification.

Two extensions shall be allowed and if the CAPA is not completed after second extension then Quality Risk Assessment report (QRM) shall be prepared by the user department.

  1. 7. How CAPA Effectiveness shall be checked:

CAPA effectiveness shall be done with Trend review of various CAPAs derived from incidents or events.

CAPA effectiveness checks include the review of the repetitive CAPAs & the same shall be considered satisfactory if no repetitive CAPA is observed.

CAPA effectiveness check can also be verified from the review system like Annual Product Quality Review, surprise checks, spot checks and during internal audit.

Spot Check can also perform for CAPA effectiveness check. Example Suppose some procedure was newly implemented in Standard operating procedure (SOP) batch record & training was imparted for the same but whether the same is followed or not that has to be checked.

  1. 8. What to check during Trending of CAPA :

CAPA effectiveness checks to be carried out at every three months.

CAPA should be review annually which contains number of CAPA initiated throughout the year, Open & closed CAPAs, number of CAPAS extended, department wise, number of CAPA closed within Target completion date (TCD) etc.

  1. 9. How to handle the CAPAs routed from regulatory and customer Audits:

Information and documents related to CAPA drawn from internal audit, customer audits and regulatory inspections are considered confidential and can be made available to regulatory review with prior approval from QA Head.

  1. 10. How to handle the regulatory CAPAs:

CAPAs with respect to regulatory commitment or submission shall strictly to be followed as per Target completion date (TCD) and any extension to TCD shall be assigned as per management and regulatory approval.

  1. 11. What are the contains of CAPA Form (but not limited to) :

The contains are CAPA number, Initiation Date, department, CAPA emerging from, Description of Non- conformance, Reference Document Number, Root cause, CAPA details, responsible person name, Target completion date, department Head Sign & date, QA head sign & date, CAPA Implementation details, CAPA effectiveness check, CAPA closer comment with sign & date of initiator & department head and Verified & Closed by QA with sign & date