SOP For CAPA Handling Procedure
SOP For CAPA Handling Procedure
SOP For CAPA Handling Procedure
1.0 PURPOSE
2.0 SCOPE
2.1 This procedure is applicable for all Corrective and Preventive Action that are
recommended if any, but not
2.1.5 OOS/OOT
3.1 References
3.1.2 PIC’s Guideline: Guide to good manufacturing practice for medicinal products
(PE009-09) Part-I.
3.2 Attachments
4.1 Definitions
CAPA is a reactive tool for system improvement which focuses on the action taken to eliminate
the cause of a detected nonconformity or other undesirable situation to prevent their recurrence
(for corrective action) or action taken to eliminate the cause of a potential nonconformity or
other undesirable
Action taken to eliminate the cause of a detected nonconformity or other undesirable situation.
NOTE: Corrective action is taken to prevent recurrence whereas preventive action is taken to
prevent occurrence.
Action taken to eliminate the cause of a potential nonconformity or other undesirable potential
situation.
NOTE: Preventive action is taken to prevent occurrence whereas corrective action is taken to
prevent recurrence
4.2 Abbreviations
5.0 RESPONSIBILITY:
5.2.1 To assign the Corrective and Preventive Action those are suggested by the
approving authorities through Corrective and Preventive Action form.
5.2.2 To assign a number to the Corrective and Preventive Action (CAPA) form.
5.2.4 To follow up and close of the Corrective and Preventive Action after review.
5.4.1 To ensure tracking, follow - up and closure of Corrective and Preventive Action.
5.5.1 To ensure tracking, follow - up and closure of Corrective and Preventive Action.
6.0 Distribution:
I. Quality Assurance
III. Production
V. Engineering
7.0 PROCEDURE:
7.1 QA shall review the approved documents (i.e. incidence/Deviations report
investigation report, change controls, Laboratory variations reports, repeat analysis
reports, OOS/OOT reports, Planned modification, Market complaints, External audits,
Internal audits, Outcome of Risk Assessment, Annual product review, management
action plan, any discrepancies where ever Corrective and Preventive Action are
suggested and shall list out CAPA in order of the decreasing effectiveness as
mentioned below:
• Elimination
• Replacement
• Facilitation
• Detection
• Mitigation
Elimination: Eliminate the possibility of error. This can be accomplished
by eliminating the task. For example, eliminate mixing errors by
purchasing pre-mixed materials.
Eliminate recording errors by linking the
measurement device to a printer. Elimination can
be also be accomplished by an error proof device.
Replacement: Change the current process by replacing it with more reliable process.
For example: Design a more robust screen for milling machines so they do
not break so often. Replace human inspection with automated 100%
inspection at the source install bar-code scanners. Facilitation: Make the
process easier to perform.
For example: Use dedicated storage areas to reduce the possibility of mix-up. Add pictures
to procedures.
Detection: Improve detection by adding new or better sensors. Do this at the source if
possible.
For example: Add audible alarms or lights if a process is out of tolerance. Better
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yet, automatically shut down, or add an interlock so the process cannot move to
the next step.
Understand that a corrective action that improve detection is inherent weaker
than a corrective action that eliminates the problem. Because detection does not
prevent defects, it just prevents escapes.
Mitigation: Minimize the effect of the error.
This is typically the weakest form of corrective action.
For example: Install a metal detector with a link of compression machine, when
metal is detected, mitigate by rejecting the product before contaminating the bin.
7.2 QA person shall enter such details into CAPA form issuance register (Attachment–I).
This CAPA form issuance register shall have following details.
7.2.1 Sr. no.: The sequential number of the CAPA shall be written.
7.2.3 CAPA No.: CAPA Number shall be entered into this column (numbering procedure
described in point No.7.6.
7.2.4 Reference document no: The document reference number in the context of which
above CAPA is assigned.
7.2.6 Responsible Person: The person responsible for the Implementation of CAPA.
7.2.9 Extended target date: If any extended target date to fulfill the recommendations.
7.2.10 Justification for extension of target date: Fill the justification for extension of
target date to fulfill the recommendations.
7.2.11 Status: On the basis of the fulfillment of the ‘status’ whether ‘open’ or ‘close’ shall
be determined.
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7.3 Based on the CAPA register entries a CAPA form (Corrective and Preventive
Action form; Attachment-II) shall be issued to concerned department. Details of
CAPA issuance procedure is described into point # 7.7.
7.4 Concerned department head shall be responsible to complete the CAPA as per
requirement and within defined time schedule.
7.5 For proper traceability CAPA No. shall be entered into subjected document from
where CAPA is initiated.
7.6 For each document a separate CAPA number shall be assigned for traceability and
tracking for example Planned deviation No., Change control No, Audit Report,
Market complaint No., Planned modification No., incident Report No., etc.
Note: If CAPA to be taken for Different documents is same then one common CAPA No. can be
issued.
7.6.1 First four characters shall be the prefix CAPA followed by a slash (/).
7.6.2 Next two characters shall comprise of the manufacturing unit code “PK”.
7.6.3 Next three characters shall comprise of the department code as per SOP for SOP
succeeded by last two
digits of the current year followed by a slash (/). (Like 20 for year 2020 and so on…).
7.6.4 Last three digits shall be the serial number beginning with 001 and shall start with
001 from 1st January of each year.
7.6.5 For example: First CAPA of the Production department of ………for the year 2020
shall be numbered as
CAPA/PK/PRD20/001.
7.7 For each CAPA the CAPA form shall be issued by QA to concerned
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Attachment-I
CORRECTIVE AND PREVENTIVE ACTION
ISSUANCE REGISTER
S. Date CAPA Reference Recommendation Responsible Responsible Target Extended Justification Status Remarks
No No. Person department target date
Document Completion for extension
No. Date of target date
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Attachment-II
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Remarks of Responsible Person:
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Sign/ Date:
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List of Attachment:
1.
2.
3.
Remarks of Evaluator:
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If not closed within the target date then attach CAPA Extension Form.
Performed By Verified By
Signature
Date
Approved By:
Attachment -III
CAPA EXTENSION FORM
CAPA No.:
1st Extension 2nd Extension 3rd Extension
Extended Target
Date
Reason for
extension
Proposed by
User
Department
Checked by
Respective
Department Head
Approved by QA
Head
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