1.0 Objective
To lay down a procedure for the Corrective and Preventive Action so as to eliminate the causes of potential non-conformities and /or encountered non-conformities in order to prevent their occurrence and / or recurrence.
2.0 Scope
This Standard Operating Procedure shall apply to all corrective and preventive action taken in pharmaceutical formulation company.
3.0 Responsibility
- Concerned Department Head and QA Head shall be responsible for identifying the need for CAPA.
- Concerned Department Head and QA Head shall be responsible for completion of the proposed CAPA.
- QA Head shall be responsible for ensuring that all CAPA identified during all investigative processes are included, maintained and updated in the record of corrective and preventive action.
4.0 Accountability
QA Head/ designee shall be accountable for implementation of this SOP.
5.0 Abbreviations and Definitions
| CAPA | : | Corrective Action and Preventive Action |
| Non-conformities | : | Non-conformities in products, manufacturing process, SOP, utility, equipment, building and facilities with respect to predetermined acceptance criteria, specification, or cGMP elements. |
| Corrective Action | : | The action taken to eliminate the causes of an existing non-conformity, defects or other undesirable situation in order to prevent recurrence, to a degree appropriate to the magnitude of problems and adequate with the risks encountered. |
| Preventive Action | : | The action taken to eliminate the causes of a potential non-conformity, defects or other undesirable situation in order to prevent occurrence, to a degree appropriate to the magnitude of problems and adequate with the risks encountered. |
6.0 Procedure
6.1 Initiation of CAPA:
6.1.1 The Concerned Department shall identify and clearly define the potential non-conformities and/or review encountered non-conformities arising out of procedures like Handling of Deviations in Facility, Standard Operating Procedures, Batch Manufacturing Record and Specifications; Internal Audits; Change Control; Handling of Product Complaints; Product Recall; Handling of Non-conforming In-process and Finished products; non-conforming delivery from vendors, etc.
6.1.2 The Concerned Department along with any other relevant department, if applicable, shall determine the causes of non-conformities.
6.1.3 The Concerned Department shall submit the corresponding document or source document (e.g NCR form, Complaint Information Form, Deviation Report, Internal Audit Report, Product Recall – Investigation and Disposition, Change Control etc.) to QA Head.
6.1.4 QA Head along with Concerned Department Head shall decide the need for the CAPA. If need identified than QA personnel shall issue the CAPA Form (Annexure –I) and allot the CAPA No., as CAPA/XXX/YY, where:
CAPA – Corrective and preventive action
“/” – ‘Slash’
XXX – Serial number, commencing from 001 in calendar year
YY – Last digit of calendar year.
e.g.: CAPA/002/16 represents 2nd CAPA in calendar year 2016.
And make relevant entries in the logbook titled “Record of Corrective and Preventive Action ( as per Annexure –II).
6.1.5 After assigning the CAPA No. QA Personnel shall write the details of the corresponding or source document (name & number).
6.1.6 The CAPA Form then shall be forwarded to the Concerned Department.
6.1.7 The Concerned Department shall fill in the form the description of identified non conformity and necessary corrective action taken and intimate to QA for verification.
6.1.8 QA personnel shall verify the non-conformity, corrective action with their impact and put their signature with date in relevant column.
6.1.9 After that Concerned Department Head shall carried out investigation to identify the cause of the non-conformity along with verification from QA Department.
6.1.10 During investigation if required concerned department shall take the comments from any other department.
6.1.11 These all investigation and comments of other department shall be verified by QA along with sign & date.
6.1.12 After completion of investigation a proposed preventive action shall be identified with their target completion date.
6.1.13 In case the proposed preventive action is not completed due to genuine reason than target completion date shall be revised by taking permission of QA Head.
6.1.14 A proper justification or reason for revised target date shall be given by Concerned Department which shall be verified by QA department.
6.2 CAPA Closure and Verification:
6.2.1 On the target completion date the Concerned Department Head shall verify that the proposed CAPA is completed within the specified time period and implemented along with associated actions.
6.2.2 QA Head shall evaluate the implementation of proposed action within the target completion date and completion of CAPA form by reviewing of supporting documents
6.2.3 If any change proposed as a result of CAPA shall be done through SOP on Change Control and reference of the same shall be mentioned in the CAPA format.
6.2.4 All change controls, deviations, discrepancies, NCR, incident reports giving rise to CAPA shall be addressed through CAPA form.
6.2.5 The record of each CAPA shall be maintained.
6.2.6 After doing all above given activities CAPA shall be closed by Head QA.
7.0 Forms and Records
7.1 CAPA Form : Annexure -I
7.2 Record of Corrective and Preventive Action : Annexure -II
7.3 Decision Tree : Annexure -III
8.0 Distribution
8.1 Master Copy – Documentation Cell (QA)
8.2 Controlled Copies – Quality Control, Quality Assurance, Stores, Production, Engineering.
9.0 History
| Date | Revision Number | Reason for Revision |
| – | – | New SOP |
Annexure-I
Initiation Date:
| CAPA No.: |
| Department :
Corresponding Document Name: Corresponding Document No.: |
| Description of Non-conformity (from corresponding recording document) :
Corrective Action Taken/ Proposed:0
Head of Concerned department (Sign /Date) |
| Verified By QA
Sign/Date |
| Investigation of non-conformity
Head of Concerned department (Sign /Date) |
| Comments from other department (If required)
Head of department (Sign /Date) |
| CAPA No.: |
| Verified by QA
(Sign/Date) |
| Proposed Preventive Action:
Target Completion Date: Revised Target completion Date ( If any): Reason for revision:
Head of Department Verified By QA (Sign /Date) (Sign /Date) |
| Evaluation & review of implemented Preventive Action:
Head of Concerned Department (Sign /Date)
Head QA (Sign/Date) |
Note: If space is insufficient for recording the information, the same can be recorded in extra sheet duly signed.
Annexure -II
|
CAPA No. |
Dept. | Initiation Date |
Completion Date |
Reason for CAPA |
Source Document Number |
Evaluation and Review of CAPA |
Compiled by (Sign/Date) |
|
| By |
Date |
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Annexure -II
