Corrective and Preventive actions (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.
Initiation of CAPA:
The initiation of CAPA requires submission of source document by concerned Department Head to QA.
Department Head shall decide the need for CAPA with Head QA.
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.
Department Head shall fill the CAPA form as under.
Date CAPA initiated
Proposed completion date
Select the department initiating the CAPA by making a P mark in appropriate box.
Select the relevant system affected by making a P mark in appropriate box. If none of the systems printed are affected select Not applicable. If any other system other than those mentioned is affected, write the system in blank spaces provided.
Write in brief the CAPA description from the source document and corrective and preventive action details.
The Department Head shall write their name with signature and date.
The department head shall send the CAPA form to QA.
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.
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
CAPA / XXX /YYY / Z
Where,
XXX: department code.
YYY: serial number, commencing at 001 for each department in calendar year.
Z: Last digit of a calendar year.
e.g. CAPA/PRD/007/5 represents the 7th CAPA from production department in calendar year 2005
DEPARTMENT CODE
Prefix
Department
QAD-Quality Assurance Dept.
QCD-Quality Control Dept.
PRD-Production Dept.
WHD-Ware House Dept.
ENG-Engineering Dept.
HRD-Human Resource Dept.
RAD-Regulatory Affairs Dept.
CAPA Closure and Verification
On completion of actions, the department head shall certify that the proposed CAPA is completed and implemented along with associated actions.
QA shall verify the implementation and completion of CAPA with review of supporting documents and certify the same.
Any change proposed as a result of CAPA shall be through the SOP on Change Control (SOP No. QAD-007) Reference of the same shall be mentioned in the CAPA format.
All Change Controls, Deviations, Discrepancy, Incident Reports giving rise to CAPA shall be addressed through CAPA form.
All facility up-gradations / Capital purchase requirements / major changes in quality system and compliance to regulatory commitments giving rise to CAPA shall be addressed through CAPA form.
The record of each CAPA shall be maintained.
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.
Initiation of CAPA:
The initiation of CAPA requires submission of source document by concerned Department Head to QA.
Department Head shall decide the need for CAPA with Head QA.
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.
Department Head shall fill the CAPA form as under.
Date CAPA initiated
Proposed completion date
Select the department initiating the CAPA by making a P mark in appropriate box.
Select the relevant system affected by making a P mark in appropriate box. If none of the systems printed are affected select Not applicable. If any other system other than those mentioned is affected, write the system in blank spaces provided.
Write in brief the CAPA description from the source document and corrective and preventive action details.
The Department Head shall write their name with signature and date.
The department head shall send the CAPA form to QA.
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.
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
CAPA / XXX /YYY / Z
Where,
XXX: department code.
YYY: serial number, commencing at 001 for each department in calendar year.
Z: Last digit of a calendar year.
e.g. CAPA/PRD/007/5 represents the 7th CAPA from production department in calendar year 2005
DEPARTMENT CODE
Prefix
Department
QAD-Quality Assurance Dept.
QCD-Quality Control Dept.
PRD-Production Dept.
WHD-Ware House Dept.
ENG-Engineering Dept.
HRD-Human Resource Dept.
RAD-Regulatory Affairs Dept.
CAPA Closure and Verification
On completion of actions, the department head shall certify that the proposed CAPA is completed and implemented along with associated actions.
QA shall verify the implementation and completion of CAPA with review of supporting documents and certify the same.
Any change proposed as a result of CAPA shall be through the SOP on Change Control (SOP No. QAD-007) Reference of the same shall be mentioned in the CAPA format.
All Change Controls, Deviations, Discrepancy, Incident Reports giving rise to CAPA shall be addressed through CAPA form.
All facility up-gradations / Capital purchase requirements / major changes in quality system and compliance to regulatory commitments giving rise to CAPA shall be addressed through CAPA form.
The record of each CAPA shall be maintained.
Copy of the completed CAPA shall be
provided to the concerned Dept. Head by QA
Department Head shall compile the CAPA information and submit the summary to the Management during GMP Committee meeting / Management Review Meeting.
Management shall review / verify the same quarterly in Management Review Meeting.
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 Vice President QA.
Department Head shall compile the CAPA information and submit the summary to the Management during GMP Committee meeting / Management Review Meeting.
Management shall review / verify the same quarterly in Management Review Meeting.
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 Vice President QA.
Source documents of CAPA are identified as:
² GMP Investigations
² Deviations
² Change control
² Laboratory (OOS) Investigations
² Internal Audit Reports
² External / Customer Audits
² Annual Product Reviews
² Regulatory Inspection Reports
² Management Action Plans
² Changes in regulatory / Pharmacopoeia requirements
² Product Failures
² Complaints
² Product recall
² Returned Goods
² Incidence Reports
² Discrepancies
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