Good Distribution Practice (GDP) – Distribution & Regulatory Requirements

Good Distribution Practice (GDP) sets the requirements for quality systems governing the storage and distribution of pharmaceutical products. Discover how Seratos supports GDP implementation, auditing, and compliance readiness across regulated supply chains.

What is Good Distribution Practice (GDP)?

Good Distribution Practice (GDP) is a set of quality guidelines for organisations involved in the storage and distribution of pharmaceutical products. It defines requirements to ensure that medicines are consistently stored, transported, and handled under suitable conditions to maintain their quality, safety, and integrity throughout the supply chain.

A Good Distribution Practice (GDP) quality system focuses on regulatory compliance, risk management, traceability, and the proper storage and transportation of pharmaceutical products. GDP is aligned with global regulatory expectations, including EU GDP guidelines and WHO standards, and is essential for maintaining product quality and ensuring compliance across the supply chain.

Why Choose Seratos for Good Distribution Practice (GDP)?

  • End-to-End GDP Support

    From gap assessments and implementation to internal audits and inspection readiness, we support the full GDP lifecycle.

  • Practical, Risk-Based Approach

    We design distribution quality systems that are not just compliant, but efficient, scalable, and aligned with real-world operations.

  • Regulatory Expertise Across Markets

    Experience with EU GDP, WHO guidelines, and national requirements ensures your supply chain stands up to regulatory scrutiny.

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Our Comprehensive GDP (Good Distribution Practice) Services

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  • A structured assessment of your existing distribution quality system against GDP guidelines and applicable regulatory requirements to identify gaps, risks, and priorities.

  • Support with designing and implementing a distribution quality system aligned to GDP, including governance, process controls, storage and transportation requirements, and supply chain oversight.

  • Guidance on developing and maintaining compliant GDP documentation, including procedures, records, logs, and distribution-related quality documents covering storage, transportation, receipt, dispatch, deviations, and returns.

  • Support the development and maintenance of risk management processes aligned with Good Distribution Practice (GDP), including the identification, assessment, control, and ongoing monitoring of risks across storage, handling, transportation, and distribution activities to ensure product quality and integrity throughout the supply chain.

  • Independent internal audits aligned with Good Distribution Practice (GDP) requirements, including applicable regional regulations (e.g., EU GDP, Health Canada, MHRA), providing a clear and objective basis for regulatory inspection readiness and ongoing compliance across distribution operations.

  • Hands-on support during GDP inspections and regulatory audits, including preparation, on-site support, and response management to ensure smooth inspections and effective outcomes.

  • Assistance with product licensing and registration processes relevant to distribution activities, including establishment licensing (e.g., MDEL), regulatory registrations, and support for market access across applicable jurisdictions.

  • Support integrating GDP quality requirements with information security and data protection considerations, including coordinated audits and compliance activities where applicable.

  • Targeted training and coaching on Good Distribution Practice (GDP), including internal auditor training, regulatory awareness, and practical support to build sustainable internal capability.

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Supported Standards & Frameworks

  • ISO logo with a globe in the background and blue text that reads 'International Organization for Standardization' and '27001'.
  • Logo of the United Nations Organization for Standardization with the acronym ISO, a globe wrapped with latitude and longitude lines, and the number 42001 beneath.
  • The ISO logo featuring a red globe with latitude and longitude lines, the large red letters 'ISO' in front, and the text 'International Organization for Standardization' wrapped around the globe.
  • ISO logo with a blue globe and the text "ISO" in large blue letters, encircled by the words "International Organization for Standardization" and the number "13485".
  • Logo of the International Organization for Standardization (ISO) with a globe and the text 'ISO 22301'.
  • Shield-shaped badge featuring the logo of the National Institutes of Standards and Technology (NIST), with the text 'CSF' underneath.
  • A badge with the logo of the National Institute of Standards and Technology (NIST), featuring a shield shape, a checkmark at the top, and the text "NIST, National Institutes of Standards and Technology, SP 800-171".
  • A certification badge with a blue and purple border, featuring a shield with circuitry design in the center. The top of the badge reads "Cybersecurity Maturey Model" with stars radiating above. A banner across the shield says "Certification."
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Good Distribution Practices (GDP) - Frequently Asked Questions

  • GDP is a set of guidelines that ensures medical products are consistently stored, handled, and transported under suitable conditions to maintain their quality and integrity throughout the supply chain.

  • GDP applies to organizations involved in the distribution of pharmaceuticals and, in many cases, medical devices, such as wholesalers, distributors, logistics providers, and importers.

  • Yes, GDP is required in many jurisdictions for pharmaceutical distribution and is often enforced through inspections, licenses, or regulatory expectations. Similar principles are commonly expected for medical device distribution.

  • GMP (Good Manufacturing Practice) focuses on how products are made, while GDP focuses on how they are stored, handled, and transported after manufacturing.

  • GDP covers areas such as storage conditions, transportation controls, traceability, supplier qualification, documentation, training, and handling of complaints and returns.

  • Preparation typically includes conducting internal audits, ensuring procedures are up to date, training staff, reviewing documentation, and verifying that storage and transportation controls are effectively implemented.