Controlling internal flows is vital to prevent issues such as temperature deviations, sample loss, or misappropriation, which could compromise study results or lead to batch recalls.
Key aspects of managing internal flows include:
Regulatory Context
Adherence to Good Manufacturing Practices (GMP) is essential, ensuring appropriate conditions for facilities, storage, and monitoring systems.
Operational Management
Optimising personnel and material flows, preventing cross-contamination, and improving workflow efficiency.
Monitoring and Traceability
Using calibrated sensors and validated traceability systems, such as Laboratory Information Management Systems (LIMS), is crucial for accurately tracking sample movement.
Managing external flows focuses on supplier selection, transport validation, and compliance with international regulations, especially for controlled substances.
Key elements in external flow management include:
Supplier Quality Assurance
Conducting initial and periodic supplier evaluations, establishing Quality Technical Agreements (QTAs), and ensuring that transport conditions meet regulatory standards.
Import/Export Procedures:
Understanding country-specific regulations, obtaining the necessary permits, and managing delays, particularly for controlled substances.
Temperature Traceability:
Implementing continuous monitoring during transport, ensuring real-time data collection to maintain compliance with GMP and ICH Q9 standards.
Proper management of both internal and external logistic flows is essential to maintaining product integrity and optimising operational efficiency in stability studies. Careful planning and the adoption of robust, proactive systems are key to success in this area, reducing the risk
of non-compliance and improving the overall quality of processes.