SOP for Corrective Action and Preventive Action (CAPA) , Difference between corrective and preventive action, Corrective Action and Preventive Action plan and CAPA template in Pharmaceuticals

 

SOP for Corrective Action and Preventive Action (CAPA) , Difference between corrective and preventive action, Corrective Action and Preventive Action plan and CAPA template in Pharmaceuticals

SOP for Corrective and preventive action (CAPA) is the concept used within cGMP to correct and prevent the occurrence of nonconformances. CAPA is helpful to enhance consistency in product, process, system, facility, testing, etc. by eliminating the identified cause due to nonconformity.

This SOP helpful for the initiation, verification / validation, impact evaluation, implementation, check effectiveness and closure system of CAPA.


SOP for Corrective Action and Preventive Action (CAPA) Corrective Action and Preventive Action plan and CAPA template in Pharmaceuticals

1.0 PURPOSE

To describe the procedure for the initiation, evaluation, assignment, verification, validation, completion and effective implementation of Corrective Action and Preventive Action (CAPA).

2.0 SCOPE

This SOP is applicable to all persons who are involved and support in all originating source of CAPA e.g. deviations, OOS, OOT, Internal audit (self-inspection), Regulatory audit compliance, Product complaints, Product Recalls, Lab incidents, Annual Product Quality Review (APQR), batch failure, Management review meeting recommendation, Risk management, etc.

3.0 RESPONSIBILITY   :

3.1 User Departments:

3.1.1.   Identify the appropriate CAPA for observed non-conformances / nonconformity.

3.1.2 Ensures the CAPA is executed, verified & validated, implemented, and completed.

3.1.3 Evaluation of risk prior to Corrective Actions and Preventive Actions (CAPA) being implemented.

3.1.4 Study impact of CAPA on the other system, document, facility, process etc.

3.1.5 Ensure implementation of all identified CAPA prior to closure of non-conformance / nonconformity.

3.1.6 Ensure the action plan is being completed on time.

3.1.7    Check effectiveness of CAPA.

3.1.8 Submitting extensions for approval.

3.2 CAPA Review Board (CRB) / CAPA team:

3.2.1 Members of the CAPA Review Board (CRB) / CAPA team should be skilled and at appropriate levels. Head QA must be a member of the CAPA team and lead the team.

3.2.2 Major responsibility of CAPA Review Board (CRB) / CAPA team is evaluation, verification, implementation, completion, and review all identified CAPA.

3.2.3 CAPA team focused on points like:

3.2.3.1 Overdue of CAPA (Not closed within timeline)

3.2.3.2 Verify CAPA close and open status. CAPA Closure trend.

3.2.3.3 Verify the CAPA success and failure. CAPA Effectiveness trend.

3.2.3.4 Discussion of CAPA effectiveness failure and suggest or change in CAPA (if required)

3.2.3.5 Repetition of same CAPA. Suggest an action plan for the repetitive CAPA.

3.3 Quality Assurance

3.3.1 Logging of CAPA and assign CAPA number. Record the details in the logbook.

3.3.2   Impact assessment of CAPA related the quality aspects.

3.3.3   Evaluation and closure of CAPA.

3.3.4   Ensure all identified CAPA and CAPA suggested by CRB or CAPA team should be implemented prior to closure.

3.3.5    Review CAPA effectiveness.

4.0 DEFINITION 

4.1 Corrective action and preventive action (CAPA):

CAPA is a systematic approach for the investigation of discrepancies / detected nonconformity/defect in an attempt to rectify and eliminate the causes of an existing/potential non-conformity and prevent their recurrence. CAPA is a concept used within cGMP.

4.2 Remedial Action      :

Action taken to improve a situation, fix or correct a non-conformance/ defect and return or achieve desirable quality and control of the product.

4.3 Corrective Action:

Action taken to eliminate the cause of a detected nonconformity or defect to prevent a recurrence. This action taken to rectify the identified cause to prevent a recurrence.

4.4 Preventive Action:

Action taken to eliminate the cause of a potential nonconformity or defect to prevent occurrence. Action taken to eliminate the identified cause to prevent occurrence.

4.5 CAPA effectiveness:

After completion of the CAPA activity, review the CAPA to verify and evaluate the effectiveness for reduction or elimination of potential causes in the future. The effectiveness of CAPA should be check to understand the success or failure of CAPA.

4.6 Nonconformance:

Nonconformance is unacceptable or questionable things that happened with the product, system, facility, documents, process, etc. directly or indirectly.

5.0      PROCEDURE:      

5.1 Initiation of CAPA and documentation of the action plan:

5.1.1 CAPA may be identified as an outcome of deviations, OOS, OOT, Internal audit, Regulatory audit compliance, Product complaints, Product Recalls, Lab incidents, Annual Product Quality Review (APQR), batch failure, Management review meeting recommendation, Risk management, etc.

5.1.2    Purpose of CAPA planning:

5.1.2.1 Correct non-conformance / defect.

5.1.2.2 Continuous improvement of quality system

5.1.2.3 Identify the potential cause of a nonconformance and prevent it in the future.

5.1.3    CAPA Team / CAPA review Board (CRB) members

5.1.3.1 QA head should lead the CAPA team / CAPA review board (CRB) and final approval of appropriate corrective and preventive actions.

5.1.3.2 CAPA team members at least have the technical and regulatory knowledge and the ability to determine the CAPA.

5.1.3.3 One person appoint from QA department and the other department members from production, packing, technical, EHS, QC, Stores, Microbiology, R & D, etc. as required.

5.1.4    Sources of nonconformances Identification (But not limited):

5.1.4.1 Deviation / Non-conformance report (NCR)

5.1.4.2 Out of specification (OOS)

5.1.4.3 Out of trend (OOT)

5.1.4.4 Internal Audits (self-inspection)

5.1.4.5 Regulatory/Customers Audits

5.1.4.6 Product Recalls

5.1.4.7 Product Complaints

5.1.4.8 Annual Product Quality Review (APQR)/ Product Quality Review (PQR)

5.1.4.9 Calibration Review

5.1.4.10 Lab Incidence

5.1.4.11 Return Good

5.1.4.12 Batch Failure

5.1.4.13 Stability Results

5.1.4.14 Risk assessment

5.1.4.15 Adverse events

5.1.4.16 Management review meeting

5.1.5 Investigation of nonconformances and root cause identification:

5.1.5.1 After identification of non-conformity starts an investigation and identify the root cause of non-conformity.

5.1.5.2 Use an appropriate technique/tool for root cause analysis e.g. 5 why or Fishbone diagram/ Ishikawa diagram / 6M.

5.1.5.3 If the proper root cause is not identified then identify the probable/assignable root cause and Quality Head should take further decision.

5.1.6    Remedial Action plan/ Immediate Action:

5.1.6.1 Remedial action / immediate action should be taken as per the respective nonconformance and the details of the action plan mention in the respective form. (depends on the type of nonconformances)

5.1.6.2 If remedial action is enough to handle the nonconformance then CAPA is not required for nonconformance.

5.1.7    Logging of CAPA & CAPA number generation:

5.1.7.1 CAPA should be logged after the decision made by QA Head and user department Head.

5.1.7.2 Based on this decision of the CAPA should be logged.

5.1.7.3 QA person should fill in the details CAPA no., date, Type of document, and the reference document no., details of the non-conformance and user / responsible department along with sign and date. Decide target dates for CAPA should be entered in the log.

5.1.7.4 QA person should enter the CAPA no. in the “CAPA form”.

5.1.7.5   CAPA should be numbered as follows,

CAPA/AAA/BB/CCC

Where,

CAPA - Corrective action and Preventive action

AAA – Initiating department code e.g. PRD for production. Click here for more code.

BB - last two digits of year in which CAPA is logged. E.g. 20 for 2020

CCC - serial number starting from 001

For example: CAPA/PRD/20/001

5.2 Impact evaluation of CAPA and verification/validation of CAPA

5.2.1 Prior to implementation of CAPA impact evaluation should be perform.

5.2.2 Corrective Action:

5.2.2.1 Recommend corrective action by the user Department with the CAPA team / CRB based on the identified root cause.

5.2.2.2 User department and CAPA team / CRB tick on the appropriate option of corrective action based on the nonconformance.

5.2.2.3 Briefly describe the details of the corrective action on the CAPA form.

5.2.3 Preventive Action:

5.2.3.1 Recommend preventive action by the user Department with the CAPA team / CRB based on the identified root cause.

5.2.3.2 Preventive action is not required in all cases of nonconformances. Sometimes preventive action is not required in that case, justification for the same should be recorded in the CAPA form by the User Department and CAPA team

5.2.3.3 Preventive action should be taken to avoid the occurrence of the same type of nonconformances in the future.

5.2.3.4 User department and CAPA team / CRB tick on the appropriate option of preventive action based on the nonconformance.

5.2.3.5 Briefly describe the details of the preventive action on the CAPA form.

5.2.4 Verification and Validation of CAPA:

5.2.4.1 CAPA should be verified for the negative impact on the product, process, or quality system and will not produce new risks or Nonconformances.

5.2.4.2 Verification must confirm through comparing, reviewing the new system with an existing proven system that specified requirements have been fulfilled and do not adversely impact the product, process, system, etc.

E.g.  Verification of newly design specification with a proven design specification

5.2.4.3 Validation must confirm through objective evidence that the new system can be consistently fulfilled and do not adversely impact the product, process, system etc.

E.g. Validation of new (changed) process or test by performing proposed process or test with multiple persons, lots to demonstrate consistent results.

5.2.5 Identify the impact of CAPA:

5.2.5.1 Corrective action and preventive action (CAPA) impact evaluation should be done on other process, batches, system, facility, materials, documents, equipment, products, stability studies, and test procedures, etc.

5.2.5.2 Impact evaluation perform by the user department with CAPA team/CRB and should be recorded.

5.2.5.3 Proposal to update procedures and documents affected by Corrective action and preventive action (CAPA) should be changed by change control procedure or Document change request (DCR).

5.2.5.4 User department and CAPA team should mention target completion date based on the risk associated with the non-conformance.

5.2.5.5 After complete impact evaluation of the nonconformance, proposed Corrective and preventive action (CAPA) should be approved by QA Head.

5. 3 Implementation of CAPA:

5.3.1 After successful impact assessment, CAPA Team / CRB and User department should be responsible to complete the CAPA before the target date.

5.3.2 As possible as CAPA should be implemented within the target completion date.

5.4      CAPA Effectiveness Check:

5.4.1 Effectiveness Check Criteria should be including the below points:

5.4.1.1 Evaluate the source of data (e.g., deviation, OOS, OOT, production lots, etc.).

5.4.1.2 Decide quantifiable criteria to meet in order to eliminate the Nonconformance (e.g., reduction in repetitive nonconformances, 50% complaints reduction, etc.)

5.4.1.3 Decide time period or the number for review of effectiveness (e.g., quarterly, number of batches, etc.) with proper rationale for the selection of time / number.

5.4.1.4 Use of statistical tools or trends for checking the effectiveness if applicable.

5.4.1.5 Also checked and reviewed for any other impact of CAPA on systems that were not evaluated previously.

5.4.1.6 Occurrence of any other nonconformance which has the same root Cause.

5.4.2   After completion of CAPA adequacy of the implemented CAPA should be checked and CAPA reviewed for its effectiveness.

5.4.3   Effectiveness of CAPA should be verify by trending and reviewing reoccurrence.

5.4.4 Decide target due date for the completion of the effectiveness check the CAPA.

5.4.5 The purpose of the effectiveness check is to confirm that the CAPA were effectively eliminated potential nonconformance causes prior to occurrence.

5.4.6 Record the description of data evaluated in CAPA form and check for CAPA is successful or not.

5.4.7 If the effectiveness check failed then investigate the reason for failure. Recommend a new root cause investigation and a new CAPA may be required.

5.4.8 All failed effectiveness checks must be reviewed by the CAPA team/CRB.

5.5      Closure of CAPA:

5.5.1 Dissemination - Ensure that information related to quality problems or nonconforming product is communicated to those directly responsible for assuring the quality of such product or the prevention of such problems by the appropriate training program.

5.5.2 This relevant information should be disseminated throughout the lifecycle of nonconformance / CAPA to the relevant persons.

5.5.3    Following Checkpoints should be considered during the closure of CAPA:

5.5.3.1 Check all objectives should be met the criteria.

5.5.3.2 Check all recommended changes should be implemented.

5.5.3.3 Completion of training should be implemented to assure that all relevant employees have understood the CAPA.

5.5.3.4 Check for any additional adverse effects of CAPA prior to closure.

5.5.4 CAPA should be close within 30 working days from the date of CAPA logging and should be entered by the QA person.

5.5.5 If CAPA is not completed within the time limit then fill the “Extension of CAPA” format for the extension of CAPA

5.5.6 Fill in the required details of the form by the user/concerned department and HOD give the justification for the extension of CAPA.

5.5.7 Reason for extension should be reviewed and approved by Head QA after consulting the User Department. The extension request provides an additional 30 days to close the CAPA.

5.5.8   Closure of CAPA preferably should not extend more than 6 months from the date of logging.

5.5.9   In case the CAPA is not closed within 6 months of logging the further action should be taken by QA Head.

5.5.10 If CAPA record contains insufficient information, Quality Assurance should
discuss the same with the user department for corrections and/or updation in the
relevant sections.

5.5.11 If at any stage cancellation of CAPA required then only QA Head may approve cancellation of CAPA. Head QA must record the justification for the decision of cancellation.

5.6  Trending of CAPA

5.6.1    CAPA log should be reviewed every first 6 working days of subsequent month for the pending status of CAPA by Quality Assurance.

5.6.2 CAPA trend shall be prepared on a 6 monthly basis. The heads of Quality Assurance must approve completed trend reports.

5.6.3 At least below mentioned parameters cover in the trend report of CAPA:

5.6.3.1 CAPA initiated department/details

5.6.3.2 CAPA closing details

5.6.3.3 Generated CAPA Number

5.6.3.4 Progress of CAPA

5.6.3.5 Overdue CAPA

5.6.3.6 Repetitive CAPA

5.6.3.7 Extension details of CAPA

5.6.3.8 CAPA Effectiveness check

5.6.4 Based on the review of trend data, Quality Assurance should identify repetitive CAPA.

5.6.5 The repetitive CAPA should be evaluated and root cause investigation or new CAPA may be required.

5.6.6 CAPA should be reviewed and discussed in the Quality Management Review meeting.

6.0 ABBREVIATIONS

cGMP current Good Manufacturing Practices

SOPStandard Operating Procedure

OOT - Out of trend

OOS – Out of Specification

CAPA - Corrective Action Preventive Action

APQR - Annual ProductQuality Review

QA – Quality Assurance

R & D – Research and development

EHS – Environment Health and Safety

QC – Quality Control

7.0 REFERENCES

7.1 ICH Q10: Pharmaceutical Quality System

7.2 21 CFR Part 211.22: Responsibilities of quality control unit

7.3 21 CFR Part 211.100: Written procedures; deviations

7.4 21 CFR Part 820.90: Nonconforming product

7.5 21 CFR Part 820.100: Corrective and preventive action

8.0 HISTORY

Not Applicable

9.0 ANNEXURES

9.1 Corrective Action and Preventive Action form

9.2 CAPA Extension Form

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