Standard Operating Procedure (SOP): Medical Supplier Operations

Document Number: MSOP-001
Version: 1.0
Effective Date: [1-1-2025]
Prepared By: [Legal ]
Approved By: [Wave Rider]

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1. Purpose

To ensure consistent and compliant procedures for the procurement, storage, handling, and distribution of medical supplies.

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2. Scope

This SOP applies to all employees and contractors involved in the medical supply chain, from procurement through delivery.

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3. Responsibilities

• Operations Manager: Oversees all supply chain activities and ensures SOP compliance.

• Procurement Officer: Sources products and verifies supplier credentials.

• Warehouse Staff: Manages inventory and ensures proper storage conditions.

• Delivery Staff: Ensures accurate and timely delivery of supplies.

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4. Procedure

4.1. Procurement

• Verify suppliers are licensed and in compliance with local and national regulations.

• Maintain a list of approved vendors.

• Ensure products meet quality standards and regulatory certifications (e.g., FDA, CE).

4.2. Receiving Supplies

• Inspect shipments upon arrival for quantity and damage.

• Verify lot numbers, expiry dates, and product integrity.

• Log all incoming inventory in the inventory management system.

4.3. Storage

• Store medical supplies in designated areas according to temperature and humidity requirements.

• Separate expired or damaged goods from active stock.

• Perform regular inventory audits (e.g., weekly, monthly).

4.4. Order Fulfillment

• Confirm customer order details against stock.

• Pick, pack, and label products carefully.

• Include relevant documentation (e.g., packing slip, MSDS, instructions for use).

4.5. Delivery and Distribution

• Use temperature-controlled transport if required.

• Obtain proof of delivery.

• Handle recalls and returns promptly according to policy.

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5. Quality Control

• Conduct regular staff training.

• Implement a corrective and preventive action (CAPA) system.

• Perform internal audits quarterly.

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6. Records and Documentation

• Maintain records for at least 5 years or as required by law.

• Keep logs for procurement, inventory, shipments, and complaints.

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7. Health and Safety

• Ensure all staff use appropriate PPE.

• Maintain clean and safe work environments.

• Report and investigate any workplace incidents.

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8. References

• [List applicable regulations, e.g., FDA 21 CFR Part 820, ISO 13485, WHO guidelines, etc.]

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9. Revision History

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Would you like this formatted as a downloadable Word or PDF document?

Absolutely — here’s a more detailed and comprehensive version of a Medical Supplier SOP, suitable for mid-to-large operations or businesses seeking ISO or regulatory compliance (e.g., FDA, ISO 13485, or WHO GDP standards).

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Standard Operating Procedure (SOP)

Title: Medical Supplier Operations
Document Number: MSOP-001
Version: 1.0
Effective Date: [Insert Date]
Department: Operations / Quality Assurance
Prepared By: [Insert Name]
Approved By: [Insert Name]

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1. Purpose

This SOP outlines the procedures and controls necessary for the compliant and efficient procurement, storage, handling, distribution, and quality management of medical supplies, ensuring product integrity, regulatory compliance, and customer satisfaction.

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2. Scope

Applicable to all personnel involved in the sourcing, receiving, inventory management, storage, order processing, shipping, and quality assurance of medical devices, pharmaceutical products, PPE, and consumables handled by [Company Name].

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3. Definitions

• GDP: Good Distribution Practice

• CAPA: Corrective and Preventive Action

• MSDS: Material Safety Data Sheet

• QA/QC: Quality Assurance / Quality Control

• SOP: Standard Operating Procedure

• ISO 13485: International standard for quality management systems for medical devices

• 21 CFR Part 820: FDA Quality System Regulation for medical devices

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4. Roles and Responsibilities

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5. Procedures

5.1 Vendor Qualification & Procurement

• Vendors must complete a Vendor Qualification Form and submit proof of:

  • Business license

  • Regulatory certificates (e.g., FDA, CE, ISO 13485)

  • Product specifications and MSDS

• Perform risk-based vendor audits (onsite or virtual).

• Maintain an Approved Vendor List (AVL).

• Procurement must issue a Purchase Order (PO) which must be approved by Finance or Management before ordering.

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5.2 Receiving and Inspection

• Deliveries must be received only at designated receiving bays.

• Perform visual inspection for:

  • Damage to outer packaging

  • Tampering evidence

  • Proper labeling and documentation

• Perform Product Verification:

  • Match PO to packing slip and invoice

  • Confirm batch/lot numbers, expiry dates, and quantity

  • Log inspection details in Receiving Log Sheet

• Quarantine goods if discrepancies or damages are found and notify QA.

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5.3 Inventory Management

• Use a Warehouse Management System (WMS) or ERP for:

  • Real-time inventory tracking

  • FIFO or FEFO system (First-Expired, First-Out for perishables)

• Label inventory with:

  • SKU

  • Lot number

  • Expiry date

  • Storage conditions

• Conduct:

  • Cycle counts (weekly/monthly based on ABC classification)

  • Annual physical audits

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5.4 Storage Requirements

• Maintain warehouse conditions as per product specification:

  • Temperature range: [e.g., 15–25°C for general medical supplies]

  • Humidity control (30–60% RH)

• Use calibrated data loggers and temperature monitoring systems.

• Designate clean areas, quarantine zones, and hazardous storage areas.

• Store controlled substances and temperature-sensitive products in secure, locked, and monitored environments.

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5.5 Order Processing & Fulfillment

• Verify orders against inventory.

• Pick and pack based on validated procedures to avoid cross-contamination or mix-ups.

• Include:

  • Invoice

  • Packing slip

  • MSDS (if applicable)

  • Handling instructions

• Use tamper-evident packaging for sensitive or high-value products.

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5.6 Distribution and Delivery

• Deliver using approved carriers with validated routes and handling practices.

• For cold chain items:

  • Use validated thermal containers with gel packs or dry ice.

  • Monitor temperature in transit using disposable or Bluetooth loggers.

• Obtain Proof of Delivery (POD) from the customer.

• Maintain a Delivery Log including:

  • Route taken

  • Vehicle ID

  • Delivery staff

  • Time of delivery

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5.7 Handling Returns and Recalls

• Return products only if:

  • Within expiration

  • Original packaging intact

  • Reason for return is documented

• Quarantine all returned goods and assess by QA before restocking or disposal.

• For product recalls:

  • Follow approved Recall Management SOP

  • Notify all affected parties

  • Maintain recall logs and submit reports to regulatory authorities if required

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5.8 Complaint Management

• Log all complaints using the Customer Complaint Form

• Classify complaints (minor, major, critical)

• QA performs root cause analysis (RCA) and initiates CAPA if necessary

• Provide resolution to the customer within defined TAT (e.g., 3–5 business days)

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6. Quality Assurance and Compliance

• Conduct internal audits every 6 months.

• Maintain staff training records; training must be:

  • Documented

  • Role-specific

  • Refreshed annually or upon changes to SOPs

• Implement CAPA process:

  • Identify non-conformities

  • Investigate cause

  • Define corrective and preventive actions

  • Follow up and close CAPA

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7. Documentation & Record Retention

All records must be:

• Legible, accurate, and indelible

• Retained for:

  • 5 years for general supplies

  • 10 years for medical devices or as per regional regulations

• Access-controlled and backed up digitally (if electronic)

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8. Health, Safety & Environmental Controls

• All personnel must wear PPE in the warehouse

• Maintain SDS (Safety Data Sheets) for hazardous items

• Emergency procedures must be visible and practiced quarterly

• Dispose of expired/damaged goods as per local biomedical waste rules

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9. References

• FDA 21 CFR Part 820

• ISO 13485:2016

• WHO Good Distribution Practices

• [Local Health Authority Regulations]

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10. Revision History