Drugstore Inspection Checklist Drugstore Inspection Checklist

 Proof of Business Registration (DTI/SEC Certificate/ CDA)
 Valid Business Permit or Barangay Clearance of Establishment
 Valid LTO (If for renewal/variation/PLI)
 Proof of Payment (Official Receipt, Oncoll Payment Slip)
 Credentials of Pharmacist (PRC ID, PTR)
 Valid agreement between franchisor and franchisee (for franchise
only)
 Organizational Chart (with name, picture, designation)
 Compilation of duties and responsibilities of each personnel
 Record of training for personnel in relation to good storage practice,
regulations, procedures and safety
 Record of orientation/training available for each personnel
 Record for personnel competency evaluation/assessment
 Certificate of Attendance to appropriate FDA Licensing Seminar
available for verification (Pharmacist/s & Pharmacy Assistants)
 Established Risk Management Plan (RMP)
 Proof of Business Registration (DTI/SEC Certificate/CDA)
 Valid Business Permit or Barangay Clearance of Establishment
 Valid LTO (If for renewal/variation/PLI)
 Proof of Payment (Official Receipt, Oncoll Payment Slip)
 Credentials of Pharmacist (PRC ID, PTR)
 Valid agreement between franchisor and franchisee (for franchise
only)
 Organizational Chart (with name, picture, designation)
 Compilation of duties and responsibilities of each personnel
 Record of training for personnel in relation to good storage practice,
regulations, procedures and safety
 Record of orientation/training available for each personnel
 Record for personnel competency evaluation/assessment
 Certificate of Attendance to appropriate FDA Licensing Seminar
available for verification (Pharmacist/s & Pharmacy Assistants)
 Established Risk Management Plan (RMP)

 STANDARD OPERATING PROCEDURES  STANDARD OPERATING PROCEDURES

a. Pharmacovigilance a. Pharmacovigilance
b. Procurement of stocks b. Procurement of stocks
c. Dispensing of pharmaceutical products c. Dispensing of pharmaceutical products
d. Storage of stocks including temperature monitoring & d. Storage of stocks including temperature monitoring &
retention of monitoring records retention of monitoring records
e. Cold chain management (if with vaccines & biologics) e. Cold chain management (if with vaccines & biologics)
f. Handling complaints f. Handling complaints
g. Handling product recall g. Handling product recall
h. Handling returned products h. Handling returned products
i. Destruction / disposal of pharmaceutical products i. Destruction / disposal of pharmaceutical products
(expired, damaged, unusable stocks) (expired, damaged, unusable stocks)
j. Sanitation programme indicating the frequency of cleaning j. Sanitation programme indicating the frequency of cleaning
and the methods to be used and the methods to be used
k. Programme for pest control k. Programme for pest control
l. Power failure contingency plan l. Power failure contingency plan

 Receipts from supplier/s  Receipts from supplier/s

 Prescription book  Prescription book
 Partial filling stamp (with date of partial filling; the quantity served  Partial filling stamp (with date of partial filling; the quantity served
and balance of the prescription un-served; name and address of the and balance of the prescription un-served; name and address of the
drugstore drugstore
 Senior Citizens record or e-file  Senior Citizens record or e-file
 PWD record or e-file  PWD record or e-file
 Generic menu cards  Generic menu cards
 Room thermohygrometer/thermometer  Room thermohygrometer/thermometer
 Refrigerator thermometer  Refrigerator thermometer
 Calibration record of equipment (e.g. thermometer, weighing scales,  Calibration record of equipment (e.g. thermometer, weighing scales,
etc.) etc.)
 Record of temperature monitoring  Record of temperature monitoring
 Signboard in front of the place of business bearing its name which is  Signboard in front of the place of business bearing its name which is
consistent with the business name registration consistent with the business name registration
 Restrictions to prevent unauthorized persons from entering the  Restrictions to prevent unauthorized persons from entering the
premises / storage areas premises / storage areas
 Designated area with LABEL for the segregation storage of expired,  Designated area with LABEL for the segregation storage of expired,
damaged, recalled or returned products damaged, recalled or returned products
Equipment used for products requiring special storage condition  Equipment used for products requiring special storage condition
(Bioref, Freezer, Uninterrupted Power Supply (UPS), Temperature / RH (Bioref, Freezer, Uninterrupted Power Supply (UPS), Temperature / RH
Monitoring Devices, etc.) If applicable only Monitoring Devices, etc.)
 Calibration certificate of Device/ Equipment If applicable only
 Generic label (with Name of the patient; Generic name of the drug;  Calibration certificate of Device/ Equipment
Brand name, if any; Manufacturer; Dosage strength; Expiry date;  Generic label (with Name of the patient; Generic name of the drug;
Directions for use; Name of pharmacist) Brand name, if any; Manufacturer; Dosage strength; Expiry date;
 White and Red Labels Directions for use; Name of pharmacist)
 Utensils, apparatus and other equipment in dispensing pharmaceutical  White and Red Labels
products  Utensils, apparatus and other equipment in dispensing pharmaceutical
(e.g. Tablet counter, spatula, graduated cylinder, etc.) products
 Ice packs, coolants, insulated carriers (for vaccines and biologics) (e.g. Tablet counter, spatula, graduated cylinder, etc.)
 Compilation of Reference Materials:  Ice packs, coolants, insulated carriers (for vaccines and biologics)
 RAs 3720, 9711, 6675, 5921, 8203, 9502  Compilation of Reference Materials:
 WHO Annex 5 – Guide to Good Distribution Practices  RAs 3720, 9711, 6675, 5921, 8203, 9502
 WHO Annex 9 – Guide to Good Storage Practices  WHO Annex 5 – Guide to Good Distribution Practices
 Philippine National Drug Formulary  WHO Annex 9 – Guide to Good Storage Practices
 Pharmacovigilance related references  Philippine National Drug Formulary
 Applicable latest issuances of FDA related to community  Pharmacovigilance related references
practice  Applicable latest issuances of FDA related to community
 Required Display Information, Education and Communication practice
Materials (Posters)  Required Display Information, Education and Communication
o Parts of a Prescription Materials (Posters)
o Correct Prescription o Parts of a Prescription
o Generic Dispensing Flowchart o Correct Prescription
o Antibiotic Dispensing (info on required prescription) o Generic Dispensing Flowchart
o Antibiotic Resistance and Proper Use of Antibiotics o Antibiotic Dispensing (info on required prescription)
o MDRP /GMAP Posters o Antibiotic Resistance and Proper Use of Antibiotics
o MDRP /GMAP Posters
Food and Drug Administration
Regional Field Office XI Food and Drug Administration
2nd Floor LCI Bldg., Quimpo Blvd. Regional Field Office XI
Ecoland, Davao City 8000 2nd Floor LCI Bldg., Quimpo Blvd.
Contact No.: (082) 273-2445 Ecoland, Davao City 8000
E-mail ad: pair-reg11@fda.gov.ph  Contact No.: (082) 273-2445
E-mail ad: pair-reg11@fda.gov.ph