FARMACIA NORHIZA

RISK MANAGEMENT PLAN



I. INTRODUCTION HISTORY FARMACIA NORHIZA (FN) is originally established as a drugs distributor and wholesaler in 1996 with the purpose of providing the community of Zamboanga Del Norte with quality and affordable medicines. The company is owned by Ma. Rhiza Dumalagan Monteclaro who eventually ventured into medical supplies and devices and has applied as a medical device distributor with the DOH/FDA in 2022. As a Drug and Medical Device Distributor, Farmacia Norhiza have the following responsibilities to ensure that all products are in good quality: • Compliance to government regulations • Distribute safe, effective & quality products that are registered with FDA • Observe good storage, good distribution and good dispensing practices • Ensure immediate recall of our products having any ADR complains from our clients and appropriate reporting of any ADRs. VISION STATEMENT Farmacia Norhiza is committed and emboldened by faith to actively promote and sustain the health of the people we serve by making ourselves available accessible to the community especially those who need utmost attention and assistance. MISSION STATEMENT It is our mission to provide counsel to those who requires medical attention and dispensing the right medication to address specific illness in close coordination with medical professionals issuing correct prescription keeping in mind the utmost safety and health of the community.

FARMACIA NORHIZA MANAGEMENT TEAM FARMACIA NORHIZA RISK MANAGEMENT TEAM Chairman : Ma. Rhiza Dumalagan Monteclaro Members : Cristy Amora Regine Satorre Radzam Cammah The Risk Management Team will review, evaluate and update this Risk Management Plan every 15th day of December. If there are any concerns and risks involved that needs immediate action, please contact the RMP Chairman at (065) 224-2562 OR (065) 224-2763. RISK MANAGEMENT COMMITMENT

Farmacia Norhiza is committed to the assurance of patient safety and its protection of public health through the implementation of its Risk Management Plan. RISK MANAGEMENT OBJECTIVE As a drug and medical device distributor and wholesaler, our general Risk Management Objective is to ensure the safety, efficacy and quality of all products including but not limited to drugs/medicines, medical supplies and devices. This encompasses compliance to regulatory actions, good storage practices, good distribution practices and compliance to legal and ethical business practices. DATA LOCK POINT This risk Management Plan is valid until December 2025 The Risk Management Plan shall be reviewed, evaluated and updated annually or as the need arises. \\

II. RISK IDENTIFICATION

III. RISK UNIVERSE Risk Classification Identified Risk Risk Analysis MP-MI Lack of Training MP-MI MP-HI for Employees MP-HI LP-HI Quality Risk Management on Low Job Satisfaction MP-HI MP-HI People Lack of communication with client LP-LI Presence of Pests LP-LI (Cockroaches/Rodents MP-MI Quality Risk Management on Risk of Flooding MP-HI Facilities and Equipment Risk of Fire LP-LI MP-MI Poor maintenance HP-HI of delivery vehicles MP-MI SOP on Purchasing MP-MI not followed MP-MI SOP on Receiving MP-MI Quality Risk Management on Deliveries not LP-LI Processes followed Overstock/ Understock/ Out of Stock High room temperature reading in stockroom Good Storage Practice Products displayed in wrong shelf Improper handling of damaged or expired products Delivery Vehicle Stalled in traffic at Good Distribution Practice high heat index Breach in security lock of delivery vehicle Expired Licenses,LTO,. Business Permit, DTI Non Compliance to Compliance to Regulatory SOP Lack of communication to Regualtory Agencies Managing Product Recalls Legend: LI – Low Impact LP – Low Probability MI – Medium Impact MP – Medium Probability HP – High Impact HP – High Probability

IV. RISK MINIMIZATION Risk Classification Identified Risk R Lack of Training for Employees Conduct Tra Quality Risk Management on Low Job Satisfaction Give Minim People Incentives Conduct of Lack of communication with client and produc Benefits an Presence of Pests Follow SOP (Cockroaches/Rodents Maintain Cl Place Impo Risk of Flooding valued prod fire extingu Quality Risk Management on regulary Facilities and Equipment Risk of Fire Regular che Always follo Quality Risk Management on Poor maintenance of equipme Processes of delivery vehicles Regular ma SOP on Purchasing vehicles not followed SOP on Receiving Follow SOP Deliveries not followed Follow SOP Overstock/ Understock/ Purchase en Out of Stock Follow SOP High room Keep stockr Good Storage Practice

Risk Minimization Work Area Schedule Person Responsible aining for Employees Office Quarterly Proprietor/Pharmacist mumn Salary, Benefits and Office Yearly Proprietor/Pharmacist training on communication Office Quarterly Proprietor/Pharmacist ct selling Office Quarterly Proprietor/Pharmacist nd Incentives ALL P for Pest Control ALL daily All personnel leanliness daily All personnel ortant documents and high duct In higher places ALL Monthly Stock Receiver/Encoder uisher should be calibrated ALL Yearly Stock Receiver/Encoder eck-up for faulty wiring ALL Monthly Proprietor/Pharmacist ow SOP on closing/opening ents ALL daily Proprietor/Pharmacist aintenance of delivery Garage Weekly Delivery/Driver P on Purchasing Office daily Purchaser P on Receiving of stocks ALL Quarterly Stock Receiver/Encoder nough stocks for 1 month Office Monthly Purchaser P on reorder point Office Monthly Purchaser room well-ventilated Stockroom Monthly Proprietor/Pharmacist

Good Storage Practice temperature reading monitor roo Good Distribution Practice in stockroom Compliance to Regulatory Products displayed keep stockr in wrong shelf Follow SOP damaged o Improper handling of Follow SOP damaged or expired products Delivery Vehicle Manage sch Stalled in traffic at high heat index Follow SOP Breach in security vehicle lock of delivery vehicle Manage all Expired Licenses,LTO, time Business Permit, DTI Non Compliance to Compliance SOP Guidelines Regular com Lack of communication to Regualtory agencies Agencies Regular che and email Managing Product Recalls Follow SOP

om temperature Stock Receiver/Encoder room organized Stockroom Monthly Proprietor/Pharmacist Stock Receiver/Encoder P for the proper handling of or expired product Stockroom Monthly Proprietor/Pharmacist P on items for destruction Office daily Stock Receiver/Encoder Proprietor/Pharmacist hedule of delivery Delivery/Driver P on securing the delivery Office daily Proprietor/Pharmacist Delivery/Driver documents and renew on Office Yearly Proprietor/Pharmacist e to SOP and Regulatory ALL All personnel mmunication with regulatory Office Yearly Proprietor/Pharmacist ecking of regulatory websites Yearly Proprietor/Pharmacist P for Product Recall Office Yearly Proprietor/Pharmacist Office

V. RISK COMMUNICATION Risk Classification Identified Risk Risk Co Lack of Training Quality Risk Management on for Employees Regular Tra People Low Job Satisfaction Meeting wi Lack of communication with client Contact Pes company Presence of Pests Remind Em (Cockroaches/Rodents to do durin situation Risk of Flooding Alert emplo emergency Quality Risk Management on Risk of Fire Facilities and Equipment Poor maintenance Hire mecha maintenanc delivery veh of delivery vehicles Train purch SOP on pur SOP on Purchasing not followed Quality Risk Management on SOP on Receiving Train receiv Processes Deliveries not on receivin followed

ommunication Key Result Indicator Well-trained Employees aining and Certificate of Training ith Employees Satisfied Employees Increase of Sales & new client st Control No Pest Present Contract with Pest Control mployees of what ng emergency No damage of Products and Important Documents oyees in any Fire prevented y situation Receipt of Fire Extinguisher anic for well maintained delivery vehicles ce/check-up of Proof of service/receipt from mechanics hicles professional fee haser to follow SOP was being followed / purchase order rchasing ver to follow SOP ng deliveries SOP was being followed / delivery receipt No discrepancies in inventories

Quality Risk Management on Processes Overstock/ Train Purch Understock/ the proper Out of Stock inventory High room temperature reading Train perso in stockroom monitoring reporting o Good Storage Practice Products displayed Regular me in wrong shelf personnel o practice an arrangemen Good Distribution Practice Improper handling of Train perso damaged or expired products proper han or expired p Delivery Vehicle Stalled in traffic at items for de high heat index Instruct del for early de Breach in security stalled in th lock of delivery heat index vehicle Assigned de Expired Licenses,LTO, in-charge to Business Permit, double lock DTI Assigned pe renew licen expiry date Compliance to Regulatory

haser/Receiver in management of Minimal occurrence of Over/under/out of stocks Stocks are enough for 1 month onnel on proper Temperature is in normal range / Temperature log g, recording and book of temperature eeting with all on Good storage nd correct product Organized shelves and storage area nt onnel on the ndling of damaged product and Monitoring data and Reports estruction livery incharge elivery to avoid he traffic at high No incident report for damaged stocks due to transit elivery No more breach in security lock if delivery vehicle o install k ersonnel to No expired licenses nse before e

Give trainin Non Compliance to personnel o SOP and Regulatory Guidelines regulatory g Compliance to Regulatory Attendance Lack of communication to Regualtory Regulatory Agencies Professiona Managing Product Recalls Asssigned p remove pro in the stock pick-up by m

ng to all on SOP and guidelines SOP Copy e to meeting with Agencies and al Organization Good communication with Regulatory Agencies Certificate of attendance, Email receipt personnel to SOP for Product Recall were being followed oduct recalled Documentation kroom ready for manufacturer

VI. RISK MONITORING AND EVALUATION Farmacia Norhiza shall review and revise the Risk Management Plan at the data lock point on December 31, 2025. Risk Monitoring shall be done on an annual basis as part of the report by the Risk Management Committee Chairman. Any additional risk management shall be updated and communicated appropriately to all concerned.

This Risk Management Plan was prepared by Ma. Rhiza Dumalagan Monteclaro for Farmacia Norhiza and was communicated and implemented on June 10, 2022. Due acknowledgement is given to Ace Rx Learning Specialists, Inc for the assistance in the making of this document. Reference: • International Conference on Harmonization (ICH) Q9 Guidelines for Quality Risk Management • FDA Module on Risk Management • ACE RX Module on Risk Management