SOP ON CORRECTIVE ACTION AND PREVENTIVE ACTION (CAPA)
PURPOSE : This Standard operating Procedure (SOP) provides the requirements for identification, evaluation, implementation, effectiveness monitoring, closure and documentation of Corrective Actions and Preventive Actions (CAPA). The CAPA system is designed to address continuous improvement of Quality Systems.
SCOPE : This procedure is applicable for all Corrective and Preventive actions initiated based on information from internal and external GxP systems, processes and records that are recommended
REFERENCE(S)
WHO TRS 908 Annex-4: Good Manufacturing Practices for pharmaceutical products: main principles
PIC’s Guideline: Guide to good manufacturing practice for medicinal products (PE009-09) Part-I.
ICH harmonized guideline : Pharmaceutical Quality System Q10
EU Guideline for GMP, Volume 4 , Chapter 1 : Pharmaceutical Quality System
Code of Federal Regulations Title 21 CFR 820.100.
CROSS REFERENCE DOCUMENTS
- Training Program for Employees.
- Change Control Management.
- Good Document Practice (GDP).
- Handling, Management and Investigation of Deviation.
- Quality Risk Management (QRM).
- Handling and Investigation of Non Conformance.
- Handling and Management of Product Complaint
- Self-Inspection Programmed
- SOP On Handling Of Online Rejection
- SOP on Handling of Out of Specification (OOS)
- SOP on Handling of Out- of Trend (OOT)
Attachment
- Corrective Action Preventive Action Issuance & Retrieval Register
- CAPA and Effectiveness Check Form.
- Flow Chart of CAPA
- CAPA TCD Extension Request
- Root cause identification for Human Error form.
DEFINITIONS
Corrective and Preventive Action (CAPA) : A concept with current Good Manufacturing Practice (cGMP) that focuses on the systematic investigation of root causes of unexpected incidences to prevent their recurrence (corrective action) or to prevent their occurrence (preventive action).
Corrective Action: Action taken to eliminate the causes of an existing non-conformity, defect or other undesirable situation, in order to prevent recurrence.
Preventative Action: Action taken to eliminate the cause of a potential nonconformity, defect or other undesirable situation, in order to prevent occurrence.
Correction: Any action that is taken to eliminate non-conformity.
Effectiveness Criteria: Measurable standards that, if met, demonstrate a corrective action has prevented recurrence of a finding/issue and/or a preventive action has a prevented a potential finding/issue before it occurred.
Effectiveness Monitoring: A post-execution assessment of CAPAs to verify that implemented actions have the desired outcome, as defined by the success criteria.
GxPs: The “x” in GxP is a variable that stands for manufacturing, clinical, laboratory, or clinical laboratory, Engineering, Warehouse etc. GxP generally refers to GMP, GDP, GLP, and GCP regulations and guidelines established by the U.S. Food and Drug Administration (FDA).
Target Completion Date (TCD): A date established as a target or goal, as for the completion of action.
4 eye Principle: The Four eyes principle is a requirement that two individuals approve some action before it can be taken. The Four eyes principle is sometimes called the two-man rule or the two-person rule.
Alternate Target Completion Date (ATCD): If action / task is not complete as per defined timeline (TCD), requires additional time (extension of TCD) for completion of action/ task and hence the new date established as a target is called as ATCD.
ATCD Level mentioned as follows ATCD
Level 1: First request for ATCD
Level 2: Second request for ATCD
RESPONSIBILITY
Originating department shall be responsible:
CAPA initiator shall be responsible for initiating and reviewing the CAPA.
CAPA initiator shall be responsible for obtaining reviews from other departments who are stakeholders in developing the CAPA.
CAPA initiator shall be responsible for assessing the impact on the activities that are to be carried out until the implementation of the CAPA and to build adequate controls during the interim period of CAPA implementation.
Head of Originating department/designee shall be responsible for:
To implement the Corrective and Preventive Action.
To complete the CAPA as per define schedule.
To verify the effectiveness check of CAPA.
Quality Assurance department Head shall be responsible for:
To ensure tracking, follow-up and closure of Corrective and Preventive Action.
To approve TCD extension request wherever applicable.
To ensure implementation of define system.
To evaluate the effectiveness check of CAPA.
Plant Head shall be responsible for:
To facilitate for effective CAPA implementation.
PROCEDURE:
SAFETY/PRECAUTION/EHS
CAPA form shall mandatory for major and critical deviation.
Only authorized copies of CAPA shall be made available with QMS documents such as deviation, Incident, Non-conformance, OOS, OOT, OOC, online rejection, etc. (but not limited to).
CAPA shall take for Human error shall report in case of quality control laboratory and microbiology laboratory.
CAPA INITIATION
CAPA shall be initiated as an outcome of QMS documents as mentioned (Out of Specification (OOS), Out Of Trend (OOT), Deviations, Non-conformance or discrepancy during GMP operation, Product Quality Complaints Any other non-conformance (but not limited to),
Concern department submit a CAPA request form along with reference document no. for which CAPA has been taken. Than QA person start issuance of CAPA form as per Attachment-II by flowing procedure.
Take a print of CAPA form and make control copy of CAPA form. QA allocate the CAPA no. as per CAPA numbering system i.e.
“CAPA/Dept. Code/ YY/NN”,
Whereas
CAPA : Corrective Action and Preventive Action
Dept. Code: Refer SOP No. AA/QAD-001 (Preparation, Review, Approval, Issuance & Retrieval of Standard Operating Procedure (SOPs)
YY : Indicate last two digit of Current year e.g. 25 for year 2025
NN : indicate serial number starting from 01 and onwards.
For Example this year first CAPA taken in production packaging department, than CAPA number shall as follows: CAPA/PKD/ 25/01
Than QA shall fill the following detail in the CAPA form i.e. Department, CAPA reference no., Ref. document no. issued by QA, TCD and category for which CAPA has been taken.
QA shall note down the CAPA detail and update the CAPA Issuance & Retrieval Register as per Attachment-I and issue a CAPA form.
Note:-The Target Completion Date (TCD) shall be assigned to each CAPA and implementation of CAPA shall be done as per defined timeline. The maximum TCD shall be assigned to each type of CAPA and TCD is assigned by Head QA/Designee.
Than concern department person fill Description detail of nonconformance, deviation etc… And immediate action in CAPA form and the supporting document (if any).
Than investigation has been conduct to identify the root cause and detail of root cause shall be mention in Root Cause identified column. Investigation shall be conducted using tools mention in Sop on Investigation.
In case any Laboratory nonconformance (Invalid, OOT, OOS, Deviation etc…) investigation will conclude Analyst Error as a root cause, “a root cause for human error” shall be done by Investigation team to derive exact root cause of human error and same shall be reviewed by designee and Head QC.
Than Responsible person/Initiator forward the CAPA form to concern department head for review.
Than concern department head fill the detail of Corrective action and Preventive action in respective columns and attached the supporting document with CAPA form, than CAPA form shall be forward to QA for review.
Proposed CAPA that require changes shall be handled as per current version of SOP “Change Control Procedure”. The changed process or systems shall be reflected in the current version of documents and training shall be imparted to concerned persons as appropriate. In such cases, TCD of CCF shall not exceed as TCD of CAPA.
After review the CAPA form by QA person, CAPA form shall be forward to QA Head/ Designee for review and approval.
Than QA Head/ Designee review the CAPA form and supporting document, decide the CAPA form is Approved or Not Approved.
After getting approval from QA head CAPA shall be implemented by concern Department. The implementation status of CAPA shall be verify by Concern Department Head/Designee and QA person with supporting document.
Note:-The CAPA implementation as per TCD shall be periodically monitored and ensured by originating department. The details of implementation shall be updated in the log book by QA as per Attachment-I.
In case, the CAPA is not implemented as per TCD, an Alternate TCD (ATCD) shall be requested by concern department in the form.
If CAPA will not be implemented as per defined timeline of second ATCD, than deviation shall be raised by the originating department and justification note shall be approved by Head QA/designee.
CAPA Closure:
QA shall verify all items have been adequately addressed during review and approval of CAPA closure.
All required steps have been completed.
All decisions and actions have been documented and approved by QA.
Verification that any revisions of approved follow-up activities are traceable to the original CAPA.
QA head/Designee review the CAPA form and evaluate that effectiveness Check of CAPA is required or not required and mention in respective column.
QA head/Designee also mention Additional Recommendation for CAPA (if any).
If the CAPA implementation is found to be satisfactory by QA head/Designee, the CAPA shall be closed.
If the CAPA implementation is found to be ineffective, QA shall return the CAPA to the CAPA initiator (Responsible Person) or concern department for further actions with a review summary.
Flow Chart of CAPA Initiation and closure .
Effectiveness Monitoring:
The review of the effectiveness shall be recorded as per Attachment-II.
QA shall review the effectiveness of CAPA along with respective department, on a regular basis.
The CAPA related to changes/improvement in practice or procedures shall be covered as a part of the effectiveness checks.
The review of the effectiveness shall be recorded as per Attachment-II.
QA shall review the effectiveness of CAPA along with respective department, on a regular basis.
The CAPA related to changes/improvement in practice or procedures shall be covered as a part of the effectiveness checks.
The effectiveness check shall be carried out based on intensity of CAPA or 30 days of its closure.
Any action plan arising out of the effectiveness check shall be completed within 15 working days.
After final review of “Effectiveness of CAPA” as per Attachment-II by Head QA enclose the form with the respective parent document through which the CAPA was identified.