GDP focuses on maintaining the quality and identity of products (especially pharmaceuticals and medical devices) during all aspects of the distribution process.
Objective:
To ensure that medicines are consistently stored, transported, and handled under suitable conditions from the manufacturer to the end-user.
Certification requirements and Key Principles:
Quality Management System (QMS): A robust system to oversee all activities, including risk management and deviation handling.
Temperature & Environment Control: Continuous monitoring of temperature and humidity, particularly for cold-chain products.
Traceability: Accurate documentation (batch numbers, dispatch/receipt details) to facilitate rapid recalls if necessary.
Personnel Competence: Regular training for staff on product security, hygiene standards, and handling protocols.
Facility Maintenance: Secure, clean, and segregated storage areas for returned, damaged, or recalled products.