Corrective and Preventive Action (CAPA) Procedure for Good Manufacturing Practice

PURPOSE

To specify the procedure for identifying root cause for a quality issue when needed,

developing a corrective and preventative action plan and implementing and documenting corrective and/or preventative actions from initiation through post implementation review.

This procedure applies to all systems at a GMP site.

RESPONSIBILITIES

Top Management shall make a decision as to whether to take action and what action to take, considering the magnitude of problems and likely risk and initiating corrective and/or preventative actions (CAPA) where applicable.

The Regulatory Department is responsible for recording of changes to documented procedures resulting from corrective and preventative action.

Top Management shall determine the corrective or preventative action needed to address or prevent a particular or potential non-conformity, including review of data and data trend on non-conforming product.

The Regulatory Department shall ensure that all relevant information on actions taken is submitted for management review.

The Management Representative shall ensure effective operation of CAPA as part of Management review.

PROCEDURE

Nonconforming item review:

When material/component/product/pack/documentation or procedure is found to be unsuitable for the required purpose/process, refer to SOP-Control of Nonconforming Product.

A CAPA shall be raised to determine the potential root cause and the corrective and/or preventive action when the CAPA may be related to a system or process failure where:

  • It is considered that the Corrective or Preventative action cannot be completed within 60 days of identification of the root cause, using day-to-day resource allocation within the owning department
  • The Corrective or Preventative action will require the establishment of a cross-functional or inter-site team
  • The non-conformance impacts on regulatory compliance
  • There is a significant chance of the nonconformance recurring
  • The defect is likely to lead to significant customer dissatisfaction
  • The Corrective or Preventative action requires a request to be raised for unbudgeted capital expenditure
  • An internal or external Regulatory Audit, Inspection or Supplier/Customer Audit which results in Non-conformances or Observations requiring corrective and preventative actions

A CAPA shall be raised as a result of trends in data from the following sub-systems:

  • Non-Conformities (including internal, external and supplier audits)
  • Customer Complaints
  • Service and Repair Reports
  • Post-Market Surveillance
  • Deviation Authorizations
  • Customer Returned Product
  • Management Review
  • Process nonconformances
  • Quality System nonconformances
  • Overviews of important and common problems from group audits

CAPA Project Management:

The nature and extent of the investigation and actions taken shall be proportionate to the significance of the problem.  The significance may be determined through a documented risk review.  The CAPA shall be assigned to the respective manager.

CAPA Decision Tree

The CAPA decision tree shall be completed by the originator circling decision points regarding the source of non-conformity, obviousness of probable root cause, whether the issue is a systematic issue, and an assessment of risk.

If a CAPA file is to be raised, the signed CAPA decision tree is sent to the Regulatory Department.

CAPA File Initiation

A CAPA number shall be issued in the format of CA/YY/nnn (where nnn is a sequential number held in CAPA Master File, and YY is the last two digits of the calendar year) and documented on in the CAPA Log when presented with information that meets the requirements for CAPA initiation by the regulatory department.

A CAPA Project Checklist shall be assigned for each file.

A CAPA Form shall be sent to the owner to complete section one (including entering the CAPA number assigned and any relevant information including the source of the CAPA (ie. Non-conformance number, complaint number, audit information and any preliminary investigation findings).

Root Cause Investigation:

The CAPA owner shall be responsible for performing the root cause investigation.

The following guidelines shall be used during completion of section two:

  • Detail a description of event and date
  • List similar events noted (if applicable)
  • Explain how the event may impact other areas, products or sites
  • List probable causes

If the root cause is not obvious, a Root Cause Analysis should be performed. 

The CAPA owner shall indicate in section two of the CAPA Form which of the root cause analysis tools have been used and what the potential root causes are.  Once complete, the form shall be sent to the Regulatory Department to obtain approval(s).

All actions taken shall be documented in the CAPA file indicating whether these actions are Investigative, Corrective or Preventative.

Action Plan

  • Determine if Corrective or Preventative Action shall to be taken.
    • If no additional action is to be taken, a justification shall be documented and the required approvals listed in section four shall be obtained.
    • If action is to be taken, complete section three of the CAPA Form.

Approvals

  • The action plan(s) require approval prior to implementation.
  • Obtain the required approvals listed in section four of the CAPA Form.

Documentation:                              

All actions (corrective and prevention) taken as part of a CAPA process must be completed in accordance with any applicable procedure and documented in the CAPA file.

Effectiveness Check                           

After implementation of the corrective or preventive action the effectiveness shall be verified using the appropriate means, e.g.

  • From the source of the non conformity, compare the data before and after implementation of the preventative action(s).
  • Process or documentation audit

N.B. In the case of item (i), a sufficient amount of time (typically one month) shall have elapsed in order to have an acceptable amount of data to make a judgment.

N.B. If there has been any recurrence of the identified problem after the corrective/preventative actions have been established and implemented, the root cause and actions shall be reviewed and the CAPA shall not be considered ready for closure.

If the effectiveness check is successful, proceed to CAPA closure.

If the effectiveness check is unsuccessful, the CAPA shall not be closed.  The CAPA will be forwarded to the CAPA owner for further investigation.

CAPA Closure

Upon a successful effectiveness check, obtain the required CAPA closure signatures

The CAPA file can be considered for closure when the following information is available:

  • The CAPA Project Checklist has been completed and signed off
  • The CAPA Decision Tree has been completed and signed off
  • The CAPA Form has been completed, the effectiveness check(s) were successful and all required signatures are received.

CAPA Review

The CAPA review shall take place in accordance with the Management Review Meetings.

The following information shall be reviewed at the meeting:

  • All new CAPA proposals shall be submitted for review. These CAPAs shall be ratified or rejected based upon significance of related event or emerging trend (risk).  If necessary, for newly accepted CAPAs and owner and resources shall be assigned.
  • A documented justification for rejecting a CAPA proposal shall be documented.
  • Resolution of issues significantly adversely affecting CAPA action completion.
  • Effectiveness reviews and closure of CAPAs.

Escalation to Top Management of cases where corrective actions are past their respective due dates, so that Top Management are aware of the implications for process quality and the resources required to address the slippage.

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