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IA Drug and Medical

The document outlines an inspection agenda for drug and medical device distributors. It includes reviewing organizational documents and records related to quality management, personnel, facilities, storage, transport and distribution activities. The inspection involves an opening meeting, document review, walk-through of warehouse facilities and transport vehicles, and an exit meeting to discuss findings. Key records to be reviewed include distribution records, import/export documents, temperature and humidity monitoring data, product complaints and recalls. The inspection evaluates compliance with good distribution practices, licensing and regulatory requirements.

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George Opu-an
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70 views3 pages

IA Drug and Medical

The document outlines an inspection agenda for drug and medical device distributors. It includes reviewing organizational documents and records related to quality management, personnel, facilities, storage, transport and distribution activities. The inspection involves an opening meeting, document review, walk-through of warehouse facilities and transport vehicles, and an exit meeting to discuss findings. Key records to be reviewed include distribution records, import/export documents, temperature and humidity monitoring data, product complaints and recalls. The inspection evaluates compliance with good distribution practices, licensing and regulatory requirements.

Uploaded by

George Opu-an
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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INSPECTION AGENDA – DRUG & MEDICAL DEVICE DISTRIBUTOR

Inspection Activity
I. Opening Meeting
 Introductions
 Inspection scope
 Attendance record

II. Document Review


2.1 Organization, Management & Personnel
 Organizational Chart
 Job Description / Duties and responsibilities of personnel involved in supply chain
 Training Plan
 Training Records
 Competency evaluation of personnel
 Qualified Person (for medical device)
 Pharmacovigilance Officer (for ADRs)
2.2 QMS & Documentation
 License to Operate
 Risk Management Plan (RMP)
 SOPs
 Franchise agreement (if applicable)
 Records
- Distribution Records
- Importation documents
- Receipts from suppliers
- Receipts issued to customers
- Product complaints
- Product recall
- Adverse Drug Reaction (ADR)Reports
- Certificates of Product Registration & Notification (for medical device)
- Batch Notifications (for antibiotics)

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- Lot Release Certificates (for vaccines)
- List of products per supplier with CPR number and its validities
- MDRP (EO 821 & EO 104 / IEC materials) / GMAP / EDPMS
2.3 Contract activities
 Distribution agreements with suppliers (quality agreements)
- With FDA Licenses (for local suppliers) / GMP Certificates / ISO 13485 QMS Certificates (for medical device)-(for
foreign suppliers)
 Agreement with third party (TP) logistics or carrier (when applicable)

III. Walk-through Inspection


3.1 Warehouse facilities
 Restrictions to entry
 Adequate/ sufficient and labeled or identified areas for products:
 Commercial stocks
 Rejects /Returns/Recalled
 Facilities & equipment
- Pallets /Racks
- Calibrated Temperature /RH Monitoring Device
- Storage conditions (must be in compliance with the recommendations of manufacturer or instructions on the label)
- Temperature monitors
 Sanitation /Pest Control Records
 Arrangement of stocks (to avoid mix-ups)
 Stock Rotation ((first expiry/first out (FEFO) system must be observed)
3.2 Records
 Recorded temperature and relative humidity (RH) monitoring data
 Calibration records of temperature/RH monitors
 Stock Reconciliation/ Inventory
 Dispatch Records
3.3 Products
 Labeling requirements
 Registration / Notification (for medical device)
3.4 Transport & Dispatch of products
 Vehicle Maintenance

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 Personnel in-charge for transport of products (must be knowledgeable on handling ie. Compliance to Storage
requirement for products)
3.6 Other Additional Requirements for TTSPPs

For Temperature-controlled rooms, cold rooms and freezer rooms:


● Uninterrupted power supply (UPS)
● Calibrated continuous temperature monitoring system
● Continuous humidity monitoring devices with sensors located at points representing humidity extremes
● Preventive maintenance on all temperature controlled rooms or equipment
● Temperature-controlled road vehicles equipped with calibrated temperature monitoring devices
● shipping containers
● Stabilizing medium: dry ice, ice or gel packs, cool water packs or warm packs, bubble wrap
V. Report Writing
● Consolidation of findings

VI. Exit Meeting


● Attendance record
● Discussion of findings /Signing of Inspection Report

124

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