Republic of the Philippines

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

RFO/CO: I/ NLC

CORRECTIVE ACTION AND PREVENTIVE ACTION PLAN

Address:
Name of Establishment:
#25 High School Drive, San Vicente West, Urdaneta City, Pangasinan
Divine Mercy Foundation of Urdaneta Hospital Pharmacy
Inspector/s: Inspection dates:
LO Myla R. Postadan and FDRO Imelda B. Calmada
25 January 2023
Prepared by: Date prepared (dd/mm/yyyy):
(Name & Designation of establishment’s authorized representative)

Note: Establishment to fill columns 3 to 5.

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

MAJOR

OTHERS Compilation of duties and CA: A separate file for each staff is

Date Effective: 02 July 2018 Rev 01

Form No. QWP-FROO-06 Annex 28
Corrective Action and Preventive Action Plan Page 1 of 5

Deficiency
Description of deficiency
number
(2)
(1)
responsibilities of personnel is
not presented
No established Risk
Management Plan
Standard Operating Procedure
on Pharmacovigilance is not
presented
SOP on procurement of stocks
is not presented
Date Effective: 02 July 2018
Form No. QWP-FROO-06 Annex 28
Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION
Filinvest Corporate City
Alabang, City of Muntinlupa
Completion or Response
Corrective Action /Preventive Inspector(‘s)
Evidence of compliance proposed completion accepted
Actions (CAPA) date dd/mm/yyyy
Comment(s)
(4) (Yes / No)
(3) (5) (6)
(7)
made which includes their duties
and responsibilities.
PA: Written duties and
responsibilities must be made for
each staff.
CA: Risk management plans are
made specifically for the pharmacy
department.
PA: There should be a specific Risk
Management Plan for the Pharmacy
which the department will follow.
CA: A written or printed copy of
the SOP for Pharmacovigilance
must be printed and known by the
pharmacists.
PA: There should be an SOP for
pharmacovigilance in order to
detect, assess, understand, and
prevent Adverse drug reaction.
CA: A copy of SOP on procurement
of stocks must be printed and
followed by the Pharmacists on duty
PA: There should be an SOP on
procurement of stocks so that repeat
orders or expiry of medicines shall
be avoided
Rev 01
Corrective Action and Preventive Action Plan Page 2 of 5
 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)

SOP on dispensing of CA: A copy of SOP of dispensing of

pharmaceutical products is not pharmaceutical products is printed
presented and known by the pharmacist.

PA:
Standard Operating Procedure
CA:
on Distribution of stocks to
different stations/ areas (e.g.
nurse station etc.) is not
PA:
presented
SOP on storage of stocks
including temperature
CA:
monitoring and retention of
PA:
monitoring records is not
presented
CA:
SOP on Cold Chain
PA:
Management is not presented
CA:
SOP on handling complaints is
not presented
PA:
CA:
SOP on handling product
recall is not presented
PA:
CA:
SOP on handling returned
products is not presented
PA:
SOP on destruction/ disposal of CA:
pharmaceutical products

Date Effective: 02 July 2018 Rev 01

Form No. QWP-FROO-06 Annex 28
Corrective Action and Preventive Action Plan Page 3 of 5
 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)
(expired, damaged, unusable PA:
stocks) is not provided
CA:
SOP on disposal of used empty
vials is not provided
PA:
SOP on sanitation programme CA:
indicating the frequency of
cleaning and the methods to be
used is not presented PA:
CA:
SOP for programme for pest
control is not presented
PA:
Record of patient medication CA:
profile/ prescription book is not
provided PA:
CA:
Record of temperature and
relative humidity monitoring is
not presented
PA:
CA: Thermohygrometer is
Results of calibration of calibrated once a year.
equipment
(thermohygrometer) is not PA: Thermohygrometers muts be
presented sent to DOST Anonas, Pangasinan
for calibration annually

For FDA use only:

Remarks

Date Effective: 02 July 2018 Rev 01

Form No. QWP-FROO-06 Annex 28
Corrective Action and Preventive Action Plan Page 4 of 5
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION
Filinvest Corporate City
Alabang, City of Muntinlupa

Recommendation(to FDA office):

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

by:

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

Date Effective: 02 July 2018 Rev 01

Form No. QWP-FROO-06 Annex 28
Corrective Action and Preventive Action Plan Page 5 of 5