Republic of the Philippines

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

QWP-ODDGFROO-3B.1-06 Annex 3.6

INSPECTION CHECKLIST
DRUGSTORE-ROUTINE

Name of Establishment

Business/Office Address

Name of Owner
LTO Number Date Issued Validity

RSN

RELEVANT COMPLIED REMARKS

PROVISIONS REFERENCES YES NO
PERSONNEL
1. Is the managing pharmacist present RA 5921 Sec. 27 /
during the time of inspection? A.O 56 s. 1989
2. Has the registered pharmacist ( ) A.O. 56 – FDA Seminar on Licensing of
Establishments
attended relevant trainings/seminars? ( ) EDPMS Seminar( ) Others: Specify:
 OR a Promissory Letter? Date of Promissory Letter
3. Does the registered pharmacist have Does he/she handle other licenses?
If yes, pls. specify
defined duties and responsibilities?
4. Are there adequate personnel to No. of Pharmacy Assistants_________
handle its operation as drug retailer?
5. Is there an Organizational Chart?
DOCUMENTARY REQUIREMENTS
6. Are the required establishment’s A.O 56 s. 1989  FDA LTO on display
proof of business registration available? Ch.II Sec 2.1.1.2
7. Are the required Pharmacist’s A.O 56 s. 1989
documents available? Ch.II Sec 2.1.1.3
& 2.1.1.4
8. Are the required proof of A.O 56 s. 1989
occupancy documents available? Ch.II Sec 2.1.1.7
9. Does the establishment have a A.O 56 s. 1989 ( ) Products complaints ( ) Product Recall
( ) Reporting of ADR ( ) Dispensing
compilation of Standard ( ) Storage ( )Cold Chain Management
Operating Procedures (SOPs)? ( ) Handling Returns/Expired/Damaged products
( ) Good housekeeping/pest control/Garbage Disposal
( ) Procurement/Stock Transfer for chain drugstore
10. Does the establishment have a A.O 56 s. 1989 ( )Textbook (Specify) ________________________
Ch.II Sec 2.2.1.2 ( ) PNDF ( ) MIMS
compilation of reference materials? Republic Acts ( ) 3720 ( ) 5921 ( ) 6675
( ) 8203 ( ) 9711 ( ) 9502
( ) A.O.#56 s. 89 ( )E.O. #821 ( )ACPR# 2009-001
11. Does the establishment have the following requirements?
11.1 Generic Menucards for 10 Essential Drugs RA 6675/
11.2 Generic Drug List A.O. 56 s. 1989
11.3 Generic dispensing flowchart AO 63 s. 1989
11.4 Generic white label
11.5MDRP Menu cards or Poster with prices RA 9502/ EO 821
11.6 GMAP menu cards or Poster with Prices ACPR 2009-001
11.7 Electronic Essential Drugs Price AO 208-0014
Monitoring System ( e-EDPMS)

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 RELEVANT COMPLIED REMARKS
PROVISIONS REFERENCES YES NO
12. Does the establishment have the AO 56 s. 1989
required record books? /RA7432/ RA9442
12.1 Prescription Book A.O 56 s. 1989
Ch.II Sec 2.2.1.3.1
12.2 Senior Citizens’ Discounts RA 7432/ RA 9257 /
A.O. 171 s. 2004
12.3Persons with Disability Discounts RA 9442 Ch VIII s32
PREMISES AND EQUIPMENT
13. Is the address of business entity written
AO 56 s. 1989 Ch II
in the application consistent with the
actual location of the establishment?
14. Is the location appropriate for the ( )Commercial ( ) Industrial ( ) Residential
establishment’s activity? Landmark:
15. Is the building suitable for the
establishment’s activities?
16. Is the structural materials of floors,
walls and ceiling appropriate for the
storage of stocks?
17. Is there a separate, secured and properly
labeled area for expired products?
18. Is there an adequate lighting to enable
operations to be carried out accurately
and safely?
19. Is there a sole access to the premises? ( ) if within a residential bldg, is there a separate entrance
( ) If sharing with other establishment, is it enclosed?
20. Is the floor area NLT15 square meters? Floor Area:
21. Is the area sufficient to allow orderly
storage of stocks?
22. Is the signage bearing the registered Material used:
business name permanently attached
and readable within 20 meters?
23. Are there adequate facilities for proper ( ) Cabinet ( ) Shelves ( ) gondola
Equipment for vaccines:
storage of drug products? ( )Bioref ( )Refrigerator ( )Generator Set
( ) Calibrated monitoring device
24. Is there adequate ventilation? ( ) Room Thermometer with updated calibration
( ) Temperature Monitoring Record

25. Is there adequate equipment/ apparatus ( ) Spatula ( )Tablet Counter ( )Graduated cylinder
( ) Ice packs for vaccines Others: _______________
for proper dispensing of drugs?
26. Is there adequate fixtures for proper ( ) tables ( ) chairs ( ) filing cabinets
( ) computer
filing of documents and recordskeeping?
27. Is there functional washing facilities
inside the drugstore premises?
PRODUCTS
28. Are the products compliant to RA 6675 Note: Collect samples when necessary
Generic labeling requirements?
29. Is there a system to assure RA 3720/RA 9711
quality of products?
30. Are the products available Note: Collect samples or confiscate products when
necessary
registered with FDA?
31. Are invoices issued by suppliers readily MC 10 s. 1990 System of filing _________________
available upon request?
 With Lot number & expiry date?

INSPECTED BY:

Food-Drug Regulation Officer (Print Name & Signature) Food-Drug Regulation Officer (Print Name & Signature)
Date: Time:

Note: Attach this Inspection checklist to the Summary of Inspection Findings/Observations

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