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1.0 OBJECTIVE:
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.
2.0 SCOPE:
This SOP shall be applicable for track and follow up open CAPA as well as verification of completed CAPA.
Corrective action:
Action taken to rectify, fix or correct a specific deviation, defect or undesirable situation.
Preventive action:
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
Deviations
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
Complaints
Product recall
Returned Goods
Incidence Reports
Discrepancies
3.0 RESPONSIBILITY:
All Department Heads
4.0 ACCOUNTABILITY:
Head Quality Assurance
5.0 PROCEDURE:
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.
5.3.3.1 Write the name of the department
5.3.3.2 Date CAPA initiated
5.3.3.3 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
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10/3/2017 SOP for Corrective Action and Preventive Action (CAPA) : Pharmaceutical Guidelines
CAPA/XXX/YYY/Z
Where,
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
DEPARTMENT CODES
6.0 ABBREVIATIONS:
6.1 SOP: Standard Operating Procedure
6.2 CAPA: Corrective Action and Preventive Action
6.3 GMP: Good Manufacturing Practices
6.4 OOS: Out of Specification
6.5 GM: General Manager
ANNEXURE-1
Request form for CAPA
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10/3/2017 SOP for Corrective Action and Preventive Action (CAPA) : Pharmaceutical Guidelines
Signature/Date
ANNEXURE-2
FORMAT FOR CORRECTIVE AND PREVENTIVE ACTION
Department Name :- Report No.
Ref. request No.(if any):-
Description :
Preventive Action :-
Acceptance Criteria :-
Approval:-
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10/3/2017 SOP for Corrective Action and Preventive Action (CAPA) : Pharmaceutical Guidelines
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