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Capa Plan 2018

This document is a corrective and preventive action plan (CAPA) form from the Republic of the Philippines Department of Health Food and Drug Administration. It contains sections for describing deficiencies found during an inspection, proposed corrective and preventive actions, evidence of compliance, completion dates, and space for inspector comments and approval. The establishment is to fill out the form with details of deficiencies identified, actions to address them, and follow-up plans to prevent reoccurrence. FDA inspectors will then review and approve the proposed CAPA.

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Cha Gabriel
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1K views3 pages

Capa Plan 2018

This document is a corrective and preventive action plan (CAPA) form from the Republic of the Philippines Department of Health Food and Drug Administration. It contains sections for describing deficiencies found during an inspection, proposed corrective and preventive actions, evidence of compliance, completion dates, and space for inspector comments and approval. The establishment is to fill out the form with details of deficiencies identified, actions to address them, and follow-up plans to prevent reoccurrence. FDA inspectors will then review and approve the proposed CAPA.

Uploaded by

Cha Gabriel
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION
Filinvest Corporate City
Alabang, City of Muntinlupa

RFO/CO:_____________________

CORRECTIVE ACTION AND PREVENTIVE ACTION PLAN


Name of Establishment: Address:

Inspector/s: Inspection dates:

Prepared by : Date prepared (dd/mm/yyyy):


(Name & Designation of establishment’s authorized representative)

Note: Establishment to fill columns 1 to 5.


Completion or Response
Deficiency Corrective Action /Preventive Inspector(‘s)
Description of deficiency Evidence of compliance proposed completion accepted
number Actions (CAPA) date dd/mm/yyyy
Comment(s)
(2) (4) (Yes / No)
(1) (3) (5) (6)
(7)
CRITICAL

MAJOR

OTHERS

Date Effective: 15 January 2018 Rev 00


Form No. QWP-FROO-06 ANNEX 28
Corrective Action and Preventive Action Plan Page 1 of 3
Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION
Filinvest Corporate City
Alabang, City of Muntinlupa

Completion or Response
Deficiency Corrective Action /Preventive Inspector(‘s)
Description of deficiency Evidence of compliance proposed completion accepted
number Actions (CAPA) date dd/mm/yyyy
Comment(s)
(2) (4) (Yes / No)
(1) (3) (5) (6)
(7)

For FDA use only:


Remarks

Date Effective: 15 January 2018 Rev 00


Form No. QWP-FROO-06 ANNEX 28
Corrective Action and Preventive Action Plan Page 2 of 3
Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION
Filinvest Corporate City
Alabang, City of Muntinlupa

Recommendation(to FDA office):

Reviewed by: Name /Designation and Signature of FDRO(s) Date:

Date:
Noted by: Name and Signature Team Leader/Supervisor

Date Effective: 15 January 2018 Rev 00


Form No. QWP-FROO-06 ANNEX 28
Corrective Action and Preventive Action Plan Page 3 of 3

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