SOP Title: Corrective Actions & Preventive Actions (CAPA)

OBJECTIVE

To define the procedure for effective handling of Corrective and Preventive Actions (CAPA) in order to ensure continual improvement and control over quality-related issues.

SCOPE

This SOP applies to the handling of CAPA related to all Quality Management System (QMS) events, including but not limited to:

• Incidents
• Deviations
• Out of Specification (OOS) / Out of Trend (OOT) / Out of Control (OOC)
• Self-inspections and audit observations
• Annual Product Quality Reviews (APQR)
• Quality Risk Assessments
• Market complaints
• External sources including regulatory inspections

RESPONSIBILITY

DEFINITIONS

• Nonconformity: A failure to meet QMS requirements in product, process, procedure, system, or structure.
• Correction: Immediate action to eliminate a detected nonconformity (e.g., rework or reprocess).
• Corrective Action: Action to eliminate the root cause of a detected nonconformity to prevent recurrence.
• Preventive Action: Action to eliminate the potential cause of a nonconformity to prevent occurrence.

PROCEDURE

CAPA Initiation

CAPA shall be initiated by the respective department when triggered by quality events, including but not limited to:

• Incident / Deviation / OOS / OOT / OOC
• Self-inspection / internal or external audit findings
• APQR, risk assessments, market complaints, recalls
• Management reviews or updates in regulatory guidelines

All CAPAs shall be documented using the CAPA Form

Following identification of the issue in the relevant QMS document, QA will issue a CAPA form upon request by the CAPA owner department.
The CAPA initiation must clearly identify:

• Source of issue
• Detailed explanation of the problem
• Available evidence supporting the issue
  Recurring or critical issues must be evaluated for systemic impact by QA.

QA shall assign a unique CAPA number using the prescribed numbering system. The CAPA owner shall fill the form accordingly.
For site-specific customer audits, CAPA shall be initiated by site QA, and CQA shall handle actions related to CQA department.

For regulatory audit observations applicable across multiple manufacturing sites, CQA shall initiate the CAPA and coordinate implementation via respective site QA teams. CAPA is initiated post receipt of audit observation.

The CAPA form must include all identified actions, responsible departments, names and signatures of action owners, and target completion dates.

CAPAs must be SMART:

• Specific
• Measurable
• Achievable
• Realistic
• Time-bound

They must involve appropriate updates to documents, procedures, systems, or processes.

CAPA timelines should consider the time required for implementation (e.g., resources, infrastructure). Finalization shall be in consultation with the user department.
If required, impact evaluation shall be conducted via the Change Control System.

For long-term CAPAs, a mid-term CAPA should be defined to mitigate risks while the long-term solution is under development.

If an improved CAPA is identified prior to implementation of the existing one, a new CAPA shall be proposed and initiated.
QA shall close the existing CAPA and assign a new CAPA number.
The improved CAPA shall be implemented via Change Control or other QMS tools as applicable.

All CAPAs must be approved by Site Quality Head / QA Head / CQA Head / Designee.

CAPA Numbering System

CAPA Number shall be assigned by QA / CQA using the following format:

PXCAPABBCCC

Where:

• PX = Site Code
• CAPA = Indicates the document type (Corrective and Preventive Action)
• BB = Last two digits of the current calendar year
• CCC = Sequential number starting from 001 for that year

CAPA Log Maintenance

QA / CQA personnel shall record the assigned CAPA Number and relevant details in the recording form titled “Corrective and Preventive Action Log.”

CAPA Form and Tracking

Details of each CAPA, including references to QMS documents or other sources, shall be recorded in Form, titled “Corrective and Preventive Action Form”, and tracked through to closure.

Resource Assessment

The CAPA Owner shall assess the resources (manpower, infrastructure, tools, etc.) needed to complete the CAPA and propose for approval from the respective Department Head.
Action completion dates shall be based on availability of resources.

Review and Timeline Adjustment

Head/Designee of the CAPA Owner Department shall review the proposed timelines. Any extension to the overall CAPA implementation timeline must be approved by the Site Quality Head / QA Head / CQA Head / Designee.

Cross-Site Applicability

CQA Head / QA Head / Designee shall evaluate and communicate whether a CAPA is applicable to other sites/units.
If applicable, the respective site QA or department shall initiate a CAPA and ensure its implementation and effectiveness verification.

Implementation of CAPA Actions

The CAPA Owner Department shall ensure that all assigned actions are completed within the defined target completion date (TCD). Each responsible department must adhere to the assigned timelines for effective CAPA execution.

CAPA Extension

All CAPA actions must be implemented within the defined TCD.
If a delay is anticipated, the CAPA Owner shall initiate a CAPA Extension Request and obtain approval in written.

• First extension: Approved by QA Head / CQA Head / Designee
• Second extension: Approved by Site Quality Head / CQA Head
• If CAPA actions remain incomplete after the second extension:
  • A Risk Assessment must be conducted
  • Based on its outcome, the pending action may be routed through appropriate QMS processes

The justification for the extension must be clearly stated in the extension request form, along with the current status of the CAPA.

Extensions may be granted on a case-by-case basis by the appropriate approving authority if additional time is justifiably required.

CAPA Document Verification and Effectiveness Criteria

Upon completion of all CAPA actions, QA / CQA shall:

• Verify implementation evidence (e.g., documents, reports, photos)
• Record the CAPA closing date
• Define effectiveness verification criteria for each action on a case-by-case basis

Effectiveness criteria may include, but are not limited to:

• Resolution of the root cause
• Correction of secondary impacts
• Establishment of preventive controls
• No adverse effects from the corrective actions
• Adequate monitoring mechanisms in place
• Sustained non-recurrence over a defined period
• Review of batch data, where applicable
• Duration and consistency of improvements post-CAPA

QA / CQA shall perform effectiveness review only after all CAPA actions are completed and supporting evidence is verified.

CAPA Effectiveness Verification and Closure

QA / CQA shall review the effectiveness of each CAPA action over a defined monitoring period, starting from the date of its implementation.

If any action is found to be ineffective:

• A Deviation shall be raised
• A new CAPA may be logged based on findings
• A Risk Assessment must be performed for any batches impacted after the ineffective CAPA

The CAPA Effectiveness Closure Date shall be recorded as the last date on which the final CAPA action was verified as effective.

Review and Trending of CAPA

Periodic Review of CAPA

The Head QA / Designee shall:

• Monitor and review the adequacy of CAPAs taken and proposed during a specified review period.
• Evaluate the implementation status of CAPAs across departments.
• Periodically review the effectiveness of CAPAs during Management Review Meetings.

CAPA Trending

• Trending of CAPA shall be prepared by QA at least once a year or as and when required.
• Trending may include analysis by:
  • Department
  • Source Document
  • CAPA Category (e.g., Training, SOP Revision, BMR Revision)
  • CAPA Implementation Status
  • CAPA Effectiveness Status
• Additional criteria may be added as needed to support quality improvement.

Vendor-Related CAPA

• Corporate Quality Assurance (CQA) shall initiate CAPAs related to vendor issues.
• These CAPAs shall be:
  • Logged in the CAPA Log
  • Monitored for completion within the defined timelines
  • Closed upon verification of effective implementation.

REFERENCES

• ICH Q7 – Good Manufacturing Practice Guidelines for Active Pharmaceutical Ingredients
• 21 CFR Part 820 – Corrective and Preventive Action
• ICH Q10 – Pharmaceutical Quality System

ABBREVIATIONS