1.0
Purpose
1.1
To lay down the 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
2.1 This SOP shall be applicable to all
corrective and preventive action taken at NAME Pharmaceuticals Ltd.
3.0
Responsibility
3.1
Concerned Department Head and
QA Head shall be responsible for identifying the need for CAPA.
3.2
Concerned Department Head and
QA Head shall be responsible for completion of the proposed CAPA.
3.3
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 Abbreviations and Definitions
4.1 CAPA : Corrective and Preventive Action
4.2 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.
4.3 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.
5.0 Materials and Equipment
5.1 None
6.0 Precaution / Health and Safety Considerations
6.1 None.
7.0 Procedure
7.1 Initiation of CAPA
7.1.1 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.
7.1.2 The Concerned Department along with any other relevant department, if applicable, shall determine the causes of non-conformities.
7.1.3 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.
7.1.4 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.
7.1.5 The CAPA shall be numbered serially in the calendar year for each department with an identification court of department. A typical CAPA form shall be numbered as CAPA/DC/YYY/ZZ . Where ,
DC: Department code
YYY : serial number commencing at 001 for each department in calendar year
ZZ : Last two digit of a calendar year.
e.g. CAPA / PR/007/24 represents the 7th CAPA from production department in calendar year 2024
7.1.6 After assigning the CAPA No. QA Personnel shall write the details of the corresponding or source document (name & number).
7.1.7 The CAPA Form then shall be forwarded to the Concerned Department.
7.1.8 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.
7.1.9 QA personnel shall verify the non-conformity, corrective action with their impact and put their signature with date in relevant column.
7.1.10 After that Concerned Department Head shall carried out investigation to identify the cause of the non-conformity along with verification from QA Department.
7.1.11 During investigation if required concerned department shall take the comments from any other department.
7.1.12 These all investigation and comments of other department shall be verified by QA along with sign & date.
7.1.13 After completion of investigation a proposed preventive action shall be identified with their target completion date.
7.1.14 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.
7.1.15 A proper justification or reason for revised target date shall be given by Concerned Department which shall be verified by QA department.
7.2 CAPA Closure and Verification:
7.2.1 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.
7.2.2 QA Head shall evaluate the implementation of proposed action within the target completion date and completion of CAPA form by reviewing of supporting documents.
7.2.3 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.
7.2.4 All change controls, deviations, discrepancies, NCR, incident reports giving rise to CAPA shall be addressed through CAPA form.
7.2.5 The record of each CAPA shall be maintained.
7.2.6 After doing all above given activities CAPA shall be closed by Head QA.
8.0 Reference Document
8.1. FDA guideline, 21CFR, sec. 820.100, subpart J- Corrective and Preventive Action
8.2. WHO, TRS-986, Annex 2, Pharmaceutical Quality System-1.5.s
9.0
Annexure
9.1 Annexure-I : CAPA FORM
9.2 Annexure-II : Record
of Corrective and Preventive Action (CAPA)
10.0 Revision History
Revision No. | Brief reason for the revision | Effective Date | Remarks |
01 | New |
|
|
11.0 Training
11.1 Head of Quality Assurance or his nominee give the training of production operator and worker.
Annexure-I
Corrective and Preventive
Action (CAPA) Form
|
Initiation
Date |
|
CAPA
No. |
|
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|
Department
|
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Corresponding
Source / Document Name |
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Corresponding Source / Document No |
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Description
of Non-conformity (From corresponding recording document):
|
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Corrective
Action Taken / Proposed:
|
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|
Head
of Concerned Department Sign
& Date |
|
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|
Verified
by QA
Sign
& Date : ……………………………. |
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Investigation
of non-conformity
|
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|
Head
of Concerned Department Sign
& Date |
|
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|
Comments
from other Department ( If required)
|
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|
Head
of Department Sign
& Date |
|
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|
CAPA
No. |
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|
Verified
by QA
Sign
& Date |
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Proposed
Preventive Action
|
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Target
Completion Date |
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|
Revised
Target Completion Date (If any) |
|
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|
Reason
for Revision:
|
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|
Head
of Department Sign
& Date |
|
Verified
by QA Sign
& Date |
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|
Evaluation
& review of implemented Preventive Action:
|
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|
Head
of Concerned Department Sign
& Date |
|
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|
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|
Head
of QA Department Sign
& Date |
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