GDP Good Distribution Practice

Standard
GDP
Edition
Validity
3 years
Surveillance
Annual surveillance audit

What is GDP?

GDP (Good Distribution Practice) is a set of standards aimed at preserving the quality and integrity of pharmaceuticals and medical products throughout all storage, transport, and distribution processes from manufacturer to end user. The EU GDP Guidelines and WHO GDP standards are the main reference frameworks.

BESA Consulting Scope

  • Assessment of warehouse and logistics processes against GDP requirements
  • Establishment of temperature and humidity management systems
  • Supply chain risk analysis and appropriate transport procedures
  • Personnel training and competency programs
  • Internal audit and certification application support

Benefits

  • Ensuring the integrity of pharmaceuticals and medical products
  • Compliance with TÜRKAK, TITCK, and EU regulatory bodies
  • Reliability and traceability across the supply chain

Certification Process

  1. 1 Application and scope definition
  2. 2 Gap analysis and documentation
  3. 3 System implementation and internal audit
  4. 4 Stage 1 and Stage 2 audit
  5. 5 Certificate issue
  6. 6 Annual surveillance and recertification

The certificate is issued by an accredited certification body; BESA manages the process from application to certificate.