FARMACIA NORHIZA

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

V. RISK COMMUNICATION Risk Classification Identified Risk Risk Communication Key Result Indicator Lack of Training Well-trained Employees Quality Risk Management on for Employees Regular Training and Certificate of Training People Low Job Satisfaction Meeting with Employees Satisfied Employees Lack of communication with client Increase of Sales & new client Presence of Pests Contact Pest Control No Pest Present (Cockroaches/Rodents company Contract with Pest Control Remind Employees of what to do during emergency Risk of Flooding situation No damage of Products and Important Documents Alert employees in any Quality Risk Management on Risk of Fire emergency situation Fire prevented Facilities and Equipment Receipt of Fire Extinguisher Poor maintenance Hire mechanic for well maintained delivery vehicles maintenance/check-up of Proof of service/receipt from mechanics of delivery vehicles delivery vehicles professional fee SOP on Purchasing Train purchaser to follow SOP was being followed / purchase order not followed SOP on purchasing Train receiver to follow SOP Quality Risk Management on SOP on Receiving on receiving deliveries SOP was being followed / delivery receipt Processes Deliveries not followed No discrepancies in inventories

Quality Risk Management on Processes Train Purchaser/Receiver in the proper management of Overstock/ inventory Minimal occurrence of Over/under/out of stocks Understock/ Out of Stock Stocks are enough for 1 month High room temperature reading Train personnel on proper Temperature is in normal range / Temperature log in stockroom monitoring, recording and book reporting of temperature Regular meeting with all personnel on Good storage Products displayed practice and correct product Organized shelves and storage area in wrong shelf arrangement Good Storage Practice Train personnel on the proper handling of damaged Improper handling of or expired product and Monitoring data and Reports damaged or expired products items for destruction Delivery Vehicle Stalled in traffic at high heat index Instruct delivery incharge Breach in security for early delivery to avoid lock of delivery vehicle stalled in the traffic at high No incident report for damaged stocks due to Expired Licenses,LTO, Good Distribution Practice Business Permit, heat index transit DTI Assigned delivery No more breach in security lock if delivery vehicle in-charge to install double lock Assigned personnel to No expired licenses renew license before expiry date Compliance to Regulatory

Give training to all Non Compliance to personnel on SOP and SOP and Regulatory Guidelines regulatory guidelines Compliance to Regulatory SOP Copy Attendance to meeting with Lack of communication to Regualtory Regulatory Agencies and Agencies Professional Organization Good communication with Regulatory Agencies Certificate of attendance, Email receipt Asssigned personnel to SOP for Product Recall were being followed remove product recalled Documentation in the stockroom ready for Managing Product Recalls pick-up by manufacturer

IV. RISK MINIMIZATION Risk Classification Identified Risk Risk Minimization Work Area Schedule Person Responsible Lack of Training Conduct Training for Employees Office Quarterly Proprietor/Pharmacist for Employees Quality Risk Management on Low Job Satisfaction Give Minimumn Salary, Benefits and Office Yearly Proprietor/Pharmacist People Incentives Conduct of training on communication Lack of communication with client and product selling Office Quarterly Proprietor/Pharmacist Benefits and Incentives Office Quarterly Proprietor/Pharmacist Presence of Pests Follow SOP for Pest Control ALL (Cockroaches/Rodents Maintain Cleanliness ALL daily All personnel Place Important documents and high daily All personnel valued product In higher places Risk of Flooding fire extinguisher should be calibrated ALL Monthly Stock Receiver/Encoder regulary Quality Risk Management on Regular check-up for faulty wiring ALL Yearly Stock Receiver/Encoder Facilities and Equipment Risk of Fire Always follow SOP on closing/opening ALL Monthly Proprietor/Pharmacist of equipments Regular maintenance of delivery ALL daily Proprietor/Pharmacist vehicles Garage Poor maintenance Weekly Delivery/Driver of delivery vehicles Follow SOP on Purchasing SOP on Purchasing Office daily Purchaser not followed Quality Risk Management on SOP on Receiving Follow SOP on Receiving of stocks ALL Quarterly Stock Receiver/Encoder Processes Deliveries not followed Purchase enough stocks for 1 month Overstock/ Follow SOP on reorder point Office Monthly Purchaser Understock/ Office Monthly Purchaser Out of Stock Keep stockroom well-ventilated High room Stockroom Monthly Proprietor/Pharmacist Good Storage Practice

temperature reading monitor room temperature Stock Receiver/Encoder in stockroom Good Storage Practice Products displayed keep stockroom organized Stockroom Monthly Proprietor/Pharmacist Good Distribution Practice in wrong shelf Stock Receiver/Encoder Compliance to Regulatory Follow SOP for the proper handling of Improper handling of damaged or expired product Stockroom Monthly Proprietor/Pharmacist damaged or expired products Follow SOP on items for destruction Office daily Stock Receiver/Encoder Delivery Vehicle Proprietor/Pharmacist Stalled in traffic at Manage schedule of delivery high heat index Delivery/Driver Breach in security lock of delivery Follow SOP on securing the delivery Office daily Proprietor/Pharmacist vehicle vehicle Office Delivery/Driver Expired Licenses,LTO, Business Permit, Manage all documents and renew on Yearly Proprietor/Pharmacist DTI time Non Compliance to Compliance to SOP and Regulatory ALL All personnel SOP Guidelines Office Regular communication with regulatory Office Office Lack of communication to Regualtory agencies Yearly Proprietor/Pharmacist Agencies Regular checking of regulatory websites and email Yearly Proprietor/Pharmacist Yearly Proprietor/Pharmacist Managing Product Recalls Follow SOP for Product Recall

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