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Good Distribution Practice in Pharmaceutical Industry

Good distribution practices (GDP) are that part of quality assurance that ensures that the quality of a pharmaceutical product is maintained by means of adequate control of the numerous activities throughout the distribution process.

As per EMA,

Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained thoughout the supply chain.

To ensure perfect implementation and compliance of GDP/GSDP requirement in your warehouse and distribution centers perfect quality system is must. The key elements of quality management system in the GDP/GSDP environment include:

  • A quality manual or GDP  manual or equivalent documentation approach;
  • A written Quality Policy describing the overall intention and requirement regarding quality;
  • A Risk Management system that ensures to consider risk approach in all GxP activity;
  • Processes are in place to assure the management of outsourced activities;
  • Procedure for self-inspection and quality audits;
  • Systems for managing returns, complaints and recalls;
  • Systems to manage changes, deviations and corrective and preventive actions (CAPAs);
  • Processes to ensure that records are made contemporaneously;
  • A formal process for reviewing the quality management system on a periodic basis (Management Review);
  • An appropriate organizational structure indicating responsibility, authority and interrelationships through authorized organization chart;
  • Include appropriate procedures, process and resources in quality system.

All parties involved in the distribution or supply chain activities should share responsibility for the quality and safety of pharmaceuticals. These responsibilities should be delineated in a quality agreement between the parties.

FDA issues revised draft guidance for track and trace of pharmaceutical products (DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs) on Jul 2022. 

This guidance identifies the standards necessary to facilitate adoption of secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain, and clarify the trading partners, products, and transactions subject to such standards.

Good Distribution Practices Checklist

  • Quality policy and Quality manual
  • Suppliers verification procedure
  • Quality documents agreement
  • Internal audit program ddetails
  • Responsibility and authority
  • GDP training details (procedure, responsible personnel, competence)
  • Hazardous materials distribution procedure
  • Receipt, storage, and distribution procedure (receipt and dispatch bays, quarantine area, storage area, storage condition etc.)
  • Facility design, construction, installation, use, and maintenance
  • Document control (format, COA, conformance to specification etc.)
  • Trace and track
  • Recall procedure
  • Returned goods procedure
  • Contract activities

Tags in: good distribution practices guidelines, good distribution practices checklist, fda good distribution practices.

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