SOP For Corrective Action and Preventive Actions
Lay down the procedure for corrective and preventive action programme in executing and documenting activities’ for continued compliance and improvement in process as per cGMP.
This SOP is applicable to the procedure for Corrective Action and Preventative Actions (CAPA) program at manufacturing facility…
Officer QA – shall prepare the SOP and maintain the CAPA Log and issue the CAPA form to user department.
Executive QA – shall review the SOP, review the identified problem and CAPA form.
Head Quality Assurance shall approve the SOP, CAPA form and ensure its proper implementation.
A Action to be taken to rectify and eliminate the non-conformance that has already occurred on evaluating the impact of non conformance.
Action taken to eliminate the cause of a potential non-conformance and prevent the non conformance from re-occurrence. In some cases the preventive action may also be taken on the basis of observation / impact analysis where nonconformity has not yet occurred but possibility of nonconformity may not be ruled out.
Numbering and login:
Where ever corrective and preventive actions are suggested, there CAPA should be following, but not limited to Incidents, Deviations, Market complaints, Out of specification result, Out of trends, Product recall, Batch failures, Self inspection / audits, Regulatory audit and commitments, Audit by contract giver, Technology transfer document, Annual product review, Environment and Safety, QC stability reports, Return goods, Other non- conformances.
QA person shall enter such details into CAPA log. This CAPA log should be access by QA controlled. CAPA shall be numbered as follows:
Where, AA: Name of Organization
“/” : Slash
CAPA: Corrective Action And Preventive Action
BBB : Sr. No. of the CAPA start from 001
CC: Last two digit of current calendar year
e.g. The first CAPA for the year 2019 is AA/CAPA/001/19.
Based on the CAPA log entries a CAPA shall be issued to concerned user department.
For each document a separate CAPA number shall be assigned for traceability and tracking.
Note: If corrective and preventive action to be taken for different documents in same system or facility then one common CAPA can be issued.
User department will be filled in corrective and preventive action format of following point of format.
Problem Description: Details description of the problem.
Source Document No. : Source document number of quality problem.
The investigation team will be a cross functional team comprising of members from various departments.
QA head /designee shall be nominate the investigation team.
Recommended persons shall be written name, department, designation and sign & date.
Note: Experience and qualified persons allowed for investigation of nonconformity.
Investigation team shall perform the investigation using the tools (not limited to the listed) defined in format Investigation tools in general used are as follows to identify root cause.
6-M framework using Ishikawa diagram (fish bone diagram), 6 M- Man, Methods, Mother Nature (Environment), Materials, Machines, Measurement 5- Why technique as per format.
Risk assessment, Failure mode effects analysis can be done during investigation.
Investigation conducted should result into conclusive root cause. However in cases where conclusive root cause cannot be found, then most probable root causes shall be assigned.
On review of CAPA investigation form and source document, the CAPA leader will initiate CAPA investigation report as per format.
Based on the root cause found, a robust corrective action(s) and preventive action(s) shall be identified.
Proposed corrective action shall be complete with in Time and proposed preventive action shall be completed within Time from date of login.
Corrective and preventive action not completed within time or target completion date then extension shall be raise. Initiator shall be request for extension of CAPA to Head Quality Assurance.
The Head Quality Assurance or designee shall authorize any extension in next target date based on the justification of extension.
Note: Extensions can be allowed for not more than three times.
Head Quality Assurance shall analysis of impact assessment based on the proposed corrective and preventive action plan.
After Head Quality Assurance signing CAPA form will be forwarded to concerned user department for the implementation of the proposed action plan. Upon completion of the activity user department will write down the details of activity along with supporting data.
After completion of above activity the duly filled and signed CAPA shall be submitted to QA department for evaluation of implementation.
QA shall be evaluated CAPA with supporting data. On the basis of evaluation corrective and preventive action log shall be updated for the status.
QA shall be write conclusions based on the evaluation.
After evaluation and conclusions QA and Head-QA shall sign in, CAPA closed by column respectively.
QA Department Personnel
All Departments Head/Managers
Annexure I – CAPA format
Annexure II – CAPA investigation tools
Annexure III – CAPA investigation form
Annexure IV – CAPA log.
Annexure V – Extension form