Premises
Our distributions sites are designed, located, constructed, and maintained to be suitable for the intended operations, offering protection from contamination, unauthorized access, and environmental extremes.
•Design: The layout facilitates logical movement and segregation, preventing mix-ups and cross-contamination. Dedicated, secured areas are provided for Quarantine, Rejected, Recalled, and Returned products.
•Security: Access is restricted to authorized personnel. Appropriate security measures are in place to prevent theft or unauthorized handling of products.
•Cleanliness: Premises are maintained to a high standard of cleanliness, with documented sanitation programs.
Heating, Ventilation and Air Conditioning System (HVAC)
•Our storage facilities maintain environmental conditions (temperature, humidity) as required by the product specifications and regulatory guidelines.
•The HVAC system (or equivalent climate control) is qualified/validated and subject to regular maintenance and calibration.
•Continuous Monitoring: Critical storage areas are equipped with validated, continuous temperature mapping and monitoring systems with alarm functions to alert personnel of excursions.
Equipment
All equipment critical to the storage and distribution of medicinal products is appropriately qualified, calibrated, and maintained.
•Calibration: Measuring equipment (e.g., thermometers, hygrometers, freezers, weighing scales) is calibrated against traceable standards on a defined schedule.
•Maintenance: A documented preventative maintenance program is in place for all critical equipment, including refrigeration units and alarm systems.
Cleaning and Sanitation
Detailed SOPs govern the cleaning and sanitation of the premises and equipment to prevent contamination, residue build-up, and pest infestation.
•Cleaning Agents: Approved cleaning and disinfectant agents are used, and the effectiveness of cleaning procedures is monitored.
•Pest Control: A documented, contract-managed pest control program is in place, covering all areas of the site.
Product Management and Warehousing
Our warehousing procedures are designed to protect the integrity of the medicinal products throughout their storage life.
The storing procedure is carried out as follows:
•Goods Receipt: Products are checked upon receipt against the purchase order and delivery note for accuracy, integrity, and regulatory status. Any discrepancies or damage are documented.
•Temperature Checks: Temperature-sensitive products are immediately moved to their required storage conditions (e.g., refrigeration or ambient).
•First-Expiry, First-Out (FEFO): Products are managed using the FEFO principle to minimize the risk of distributing expired stock.
•Segregation: Physical or electronic segregation is maintained between different stock statuses (e.g., Sellable, Quarantine, Rejected, Recalled).
Quarantine and storage of finished packaged products
•Quarantine: All incoming products are initially placed under Quarantine status (physically or electronically) until formally released by the QP/QA.
•Sellable Storage: Released products are stored in designated areas under controlled environmental conditions, continuously monitored.
