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Compliance & Quality Standards

Understanding GDP requirements, pharmaceutical regulations, and quality compliance for your fulfillment operations

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GDP RequirementsLot TrackingCertificationsDocumentationAudits & Inspections

GDP Requirements

Good Distribution Practice (GDP) Compliance

3PL SHIP operates under strict GDP guidelines to ensure quality and safety of pharmaceutical products.

Temperature-Controlled Storage

  • Climate-controlled warehouse (15-25°C / 59-77°F)
  • Refrigerated storage (2-8°C / 36-46°F)
  • Frozen storage (-20°C / -4°F)
  • 24/7 temperature monitoring with alerts

Secure Handling

  • Controlled access areas
  • Segregated storage zones
  • Qualified personnel training
  • Chain of custody tracking

Regulatory Compliance

  • FDA-registered facility
  • DEA-compliant for controlled substances (where applicable)
  • State pharmacy board registrations
  • EU GDP guidelines compliance (international)

Lot Tracking & Traceability

Lot Number Tracking

Track every unit by lot number and expiration date for complete traceability.

  1. Lot numbers recorded at receiving
  2. Expiration dates tracked for each lot
  3. FIFO (First In, First Out) inventory management
  4. FEFO (First Expired, First Out) for expiring products
  5. Lot-specific order fulfillment
  6. Complete recall readiness

Product Recalls

In the event of a product recall, our lot tracking system enables rapid identification and isolation:

  • Identify affected inventory by lot number
  • Quarantine affected stock immediately
  • Generate list of orders with recalled lot
  • Customer notification support
  • Return and destruction documentation

Certifications & Licenses

Current Certifications

  • ✓ FDA-Registered Facility
  • ✓ State Pharmacy Licenses
  • ✓ GDP Certified
  • ✓ ISO 9001:2015
  • ✓ SOC 2 Type II

Specialized Handling

  • ✓ Dietary Supplements
  • ✓ OTC Medications
  • ✓ Cosmetics
  • ✓ Medical Devices
  • ✓ Controlled Substances (licensed)

Required Documentation

Client Documentation Requirements

To store and fulfill regulated products, you may need to provide:

  • Product Documentation:
    • Product labels and ingredient lists
    • Safety Data Sheets (SDS)
    • Certificate of Analysis (COA)
    • Product specifications
  • Business Documentation:
    • Business license
    • FDA registration (if applicable)
    • Product liability insurance

Audits & Inspections

Regular Audits

3PL SHIP undergoes regular internal and external audits to maintain compliance:

  • • Internal quality audits (quarterly)
  • • External GDP audits (annual)
  • • Regulatory inspections (as scheduled)
  • • Client audits (upon request)

Client Audit Requests:

You may request to audit our facility and processes. Contact compliance@3plship.com to schedule.

Compliance Questions?

Our compliance team is available to answer questions about regulations, certifications, and quality standards

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