Compliance

Quality & GDP

GDP-aligned storage, handling, and transportation procedures that preserve product integrity from receipt through cross-border dispatch.

Good Distribution Practice (GDP) standards govern how pharmaceutical products are stored, handled, and transported to protect quality and integrity. McHade aligns warehousing, fulfillment, and cold-chain operations to GDP practices your QA team can document.

From climate-controlled storage and pick-and-pack fulfillment to 2–8°C cold-chain handling where required, operational controls are designed for regulatory scrutiny — not generic logistics.

GDP-aligned operations work alongside McHade DSCSA pedigree support and export documentation — each standard reinforces product integrity across the supply chain.

Who it's for

Built for partners whose QA teams scrutinize every handoff

  • International manufacturersStore and fulfill product from a licensed facility with GDP-aligned handling procedures.
  • Specialty & biologic partnersProtect temperature-sensitive products with controlled handling and documented chain of custody.
  • QA & regulatory teamsReceive operational documentation aligned to GDP expectations for audit and filing.

What's covered

Scope and requirements

  • GDP-aligned storage and handling procedures
  • Climate-controlled warehousing for Rx and specialty products
  • 2–8°C cold-chain aware handling where required
  • Validated shipping systems for refrigerated transit
  • Operational controls supporting consistent quality outcomes
  • Documentation for partner QA review and regulatory filing

How it works

How McHade applies GDP-aligned standards

A clear operating path from product requirements through documented release at dispatch.

1

Define product requirements

Confirm storage conditions, handling constraints, volumes, and quality documentation needs.

2

Align procedures

Map receiving, storage, fulfillment, and dispatch workflows to GDP-aligned controls.

3

Execute & monitor

Operate under defined handling protocols with temperature oversight where products require it.

4

Document & release

Provide quality records with each shipment for partner QA and regulatory review.

Discuss Quality & GDP

Share your product profile, storage and handling requirements, and destination markets. Our team will review the scope and respond with a GDP-aligned approach — turnaround depends on product complexity and market requirements.