Good Distribution Practice (GDP)

The wholesale trade in medicines plays an important role  in the field of integrated supply chain management. The quality and integrity of medicines may be affected by a lack of adequate control in the integrated supply and production chain management. To this end, the Commission has produced guidelines for the correct distribution of medicinal products for human use. These are administered in the form of a Good Distribution Practice (GDP) guideline of the Commission: 94/C 63/03 (94 KB).

The current Good Distribution Practice (GDP) guidelines are based on Article 84 of Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 for establishing a Community code relating to medicinal products for human use (Directive 2001/83/EC).

What does GDP mean?

Good Distribution Practice (GDP) guidelines provide that distributors of pharmaceutical products perform their procedures and activities in accordance with the prevailing PGD standards. GDP is, therefore, that part of the pharmaceutical quality assurance system that ensures that products are stored and transported in a consistent way and handled under the correct circumstances.

The guidelines  ensures that your entire production chain is provided with consistent quality management systems, from the very first delivery of raw materials to the factories, to the last shipment of the finished medicines to the end user.

By means of the correct and consistent management of quality-management systems, quality assurance and quality control (QA/QC), APG Pharma ensures the proper compliance of its products with the full range of relevant industrial quality manuals and guidelines such as the GDP. As part of this, our APG Pharma GDP guidelines are aimed at maintaining the consistent product quality and safety of our pharmaceutical products during the distribution process.

APG Pharma GDP summary



GDP

Goal


Shielded unloading bays

 

  • Protection against weather influences

Suitable building

 

  • Suitable and adequate for storage and distribution

Separation of products

 

  • Prevention of cross-contamination

Status indication



  • Separation of incoming, released,, return and quarantine goods

Inventory management

 

  • Fifo / Fefo

Access control

 

  • Prevention of unauthorised access

Employees’ qualifications



 

  • Correct appropriate education and training (demonstrable)
  • Accurate description of tasks, powers and responsibilities (also for temporary staff)

Conditions of storage space


 

  • Storage as specified by manufacturers RH/T/Light
  • Free of debris, dust and vermin (demonstrable)

Receipt/delivery of goods

 


  • Check that packaging is sound and undamaged in accordance with the order

Traceability guarantee

 

  • Registration of origin and destination of goods

Returns and recalls



 

  • Store returned, unsound materials separately from standard stock.
  • Delivery only after review and approval.
  • Recall procedure tested periodically

Documentation


  • Procedures and work instructions

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