To lay down the procedure for to be followed for administration of Corrective and Preventive actions (CAPA) including tracking and reporting of the status of CAPA.
This SOP shall be applicable for track and follow up open CAPA as well as verification of completed CAPA.
Action taken to rectify, fix or correct a specific deviation, defect or undesirable situation.
Action taken to eliminate the cause of deviation, defect, or other undesirable situation in order to prevent the future occurrence of such or similar an event.
Source documents of CAPA are identified as:
- GMP Investigations
- Laboratory (OOS) Investigations
- Internal Audit Reports
- External / Customer Audits
- Annual Product Reviews
- Regulatory Inspection Reports
- Management Action Plans
- Changes in regulatory / Pharmacopoeia requirements
- Product Failures
- Product recall
- Returned Goods
- Incidence Reports
All Department Heads
5.1 Source document shall provide the proposed corrective and preventive actions. The proposed corrective and preventive actions shall be approved by QA prior to implementation. The proposed corrective and preventive actions shall be verified during CAPA evaluation in form.
5.2 The "CAPA" form shall be treated as a tracking form of Corrective and Preventive actions from source document.
5.3 Initiation of CAPA:5.3.1 Department Head shall decide the need for CAPA during initiation of any source document mentioned in Scope.
5.3.2 The Department Head shall get a CAPA form issued from QA. QA shall write the source document name and Source document number on the form before issue of form. Record of CAPA form issued shall be maintained by QA.
5.3.3 Department Head shall fill the CAPA form as under.
126.96.36.199 Write the name of the department
188.8.131.52 Date CAPA initiated
184.108.40.206 Proposed completion date
5.3.4 Carry out root cause analysis and write description based on the source document.
5.3.5 Write in brief the CAPA description from the source document and corrective and preventive action details.
5.3.6 The Department Head shall write their name with signature and date.
5.3.7 The department head shall send the CAPA form to QA.
5.3.8 GM QA / Designee shall allot a reference number to the CAPA form and make relevant entries in the CAPA log. Forward the CAPA form to the concerned department.
5.3.9 The CAPA shall be numbered serially in the calendar year for each department with an identification code of department. A typical CAPA form shall be numbered as
XXX: department code.
YYY: serial number, commencing at 001 for each department in calendar year.
Z: Last two digits of a calendar year.
e.g. CAPA/PRD/007/15 represents the 7th CAPA from production department in calendar year 2015
QAD - Quality Assurance Dept.
QCD - Quality Control Dept.
PRD - Production Dept.
WHD - Ware House Dept.
ENG - Engineering Dept.
EHS - Environment Health & Safety Dept.
5.4 CAPA Closure and Verification:5.4.1 On completion of actions, the department head shall certify that the proposed CAPA is completed and implemented along with associated actions.
5.4.2 QA shall verify the implementation and completion of CAPA with review of supporting documents and certify the same.
5.5 Any change proposed as a result of CAPA shall be through the SOP on Change Control. Reference of the same shall be mentioned in the CAPA format.
5.6 All Deviations, Discrepancy reports giving rise to CAPA shall be addressed through CAPA form.
5.7 All facility up-gradations / Capital purchase requirements / major changes in quality system for compliance to regulatory commitments giving rise to CAPA shall be addressed through CAPA form.
5.8 The record of each CAPA shall be maintained.
Copy of the completed CAPA shall be provided to the concerned Dept. Head by QA. A copy of CAPA form shall be attached to the source document.
5.9 Department Head shall compile the CAPA information and submit the summary to the Management during GMP Committee meeting / Management Review Meeting.
5.10 Management shall review / verify the same quarterly in Management Review Meeting.
5.11 Information and documents related to CAPA drawn form internal audits, external/ Customer audits and regulatory inspections are considered confidential and can only be made available to regulatory review when approved by Director Technical and Sr. Vice President.
Originating Department Name
Present Process / Problem :
Proposed Action (If any ):
Acceptance Criteria of proposed action :
Approval by Head of Originating Department :
Department Name :- Report No.
Ref. request No.(if any):-
Target date of completion
Preventive Action :-
Acceptance Criteria :-
Head Originating department Head Quality Assurance
Implementation and Follow up verified by
Originating department Quality Assurance
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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