FDA Inspection Checklist

(ACERON MINI DRUGSTORE, my SUPER DRUGSTORE)

Instruction: 1. Make sure you have a clear folder for these documents Date Checked: __________________________
2. Make sure you have soft copy of this in the computer Checked By : ___________________________

No. Item Checklist Remarks Yes No

1 LTO Application Form Properly filled out, notatirzed and with signature o o
2 Proof Of Business Registration
DTI o o
Business Permit Should be the same Address with LTO o o
Barangay Clearance Should be the same Address with LTO o o
COR from BIR o o
3 Credentials of Pharmacist and PA
Pharmacist
Pharmacist PRD ID o o
Resignation Letter of Pharmacist from previous employer with signature of previous employer o o
Resignation should have LTO No of previous employer indicating the LTO No of previous employer o o
With seminar on licensing establishment for Drugstore o o
Duties and Responsibilities of Pharmacist o o
Pharmact Assistant
Pharmacy Assistant Certificate of Training of Pharmacy Assts. post in the wall o o
4 Risk Management Plan
Check the risk management plan if applicable to your drugstore Get from Lemuel
SOP mandates by FDA make sure you always have a copy of this
SOP mandates by FDA First page should always be signed in same year.
Aftersales o o
Cold Chain Management o o
Dispensing make sure your PA knows this. o o
Disposal of Expired Products, Product Return o o
Good HouseKeeping make sure your PA knows this. o o
Product Recall o o
Purchasing make sure your PA knows this. o o
Reporting of ADR o o
Storage o o
5 Location Plan This should be the one with coordinates o o
6 Picture of Drugstore with Display Of Signage o o
7 Records of Sales Invoice from Supplier Hard copy ng sales invoice from Supplier o o
8 Prescription Book or e-file should be 2 years o o
9 Senior Citizen Book and PWD o o
10 Thermometer / Daily Reading o o
11 Organizational Chart should be displayed na makikita ng patient o o
12 GMAP o o
MDRP o o
Generic Flow Chart o o
13 Reference Materials Tell na me internet tayo. Check if this is valid answer
RA 3720, PNDF, Standard Practice Guidelines o o
Pharmacovigilance-related References o o
o o