Good Distribution Practices for APIs - EU Commission Publishes Draft Guideline

"Guidelines on the principles of good distribution practices for active substances for medicinal products for human use" is the complete title of a guideline published for consultation by the EU Commission on its News Section a few days ago. The new guideline is addressed to distribution organisations and  distributors involved in the procuring, import, exporting, holding or supplying active substances. Re-packaging, re-labelling or dividing up of batches are activities out of the scope of this guideline. These are manufacturing activities which are regulated by the principles of GMP for APIs laid down in ICH Q7 and Part 2 of the EC GMP Guide respectively.

According to the requirements of the guideline, distributors and distributing companies have to maintain a quality system. In total, the guideline contains 14 topics detailing how to elaborate this quality system:

  • Quality System
  • Personnel
  • Documentation
  • Orders
  • Procedures
  • Records
  • Premises and equipment
  • Receipt of goods
  • Storage
  • Deliveries
  • Transfer of information
  • Returns
  • Complaints and recalls
  • Self-inspections

Regulations for the topics named above are partly very strict. For example, all documentation - based on electronic systems - should comply with the requirements laid down in Chapter 5.4 of Part 2 of the EC GMP Guide or its Annex 11. Furthermore, the following applies to the storage conditions for APIs: they should be stored apart from other goods and - especially - under the conditions specified by the manufacturer (e.g. controlled temperature and humidity). The records regarding the monitoring of these conditions should be made and maintained periodically, and should be reviewed regularly by the person responsible for the quality system. According to the requirements on transfer of information, the customer should always receive a copy of the original active substance manufacturer. Last but not least, the distributor is obliged to conduct self-inspections to prove the implementation of and compliance with this guideline.

The draft guideline can be found in the News section of the EU Commission website and can be commented on by 30 April 2013 at the latest. Click here to open the draft document.

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