Quality, safety, and efficacy of pharmaceutical products rely on the appropriate storage and transportation conditions. Organisations having a Wholesale Distribution Authorisation (WDA) should prove that medicines are stored and distributed within the approved temperature ranges. Proper temperature mapping and cold chain WDA procedures assist in identifying environmental risks, proving that storage and distribution conditions are valid, ultimately leading to compliance with Good Distribution Practice. A proper validation programme will lead to a reduction in product losses with a consistent response to regulations.
Core GDP Rules for Cold Chain
Cold chain management under GDP requires continuous temperature control, documented monitoring, and validated storage and transport processes. Ensure suitable environmental conditions for pharmaceutical products and examine any non-compliances of temperature excursions. GDP temperature mapping requirements are beneficial for organizations to validate whether those warehouses, refrigerators, and transport vehicles are under approved temperatures during each distribution process to ensure product quality.
Executing a Compliant Mapping Study
A compliant temperature mapping study should evaluate storage conditions under different environmental scenarios to identify temperature variations and potential risks. Since warehouse temperature is subject to great variations between summer and winter, the seasonal study has been identified as the major study. It should also validate, under different storage conditions, whether the product has been protected.
- Seasonal mapping during both summer and winter conditions
- Strategic probe placement throughout the storage area
- Identification of hot spots and cold spots
- Loading scenario tests with different storage capacities
Data Loggers & Calibration
Accurate temperature monitoring requires calibrated equipment. Companies should validate their current data logging equipment, which can continuously record the storage environment and produce reports. Equipment should be calibrated regularly to provide continued confidence in the accuracy of monitoring results. Records of calibration and maintenance schedules as well as monitoring results provide evidence that conditions are being controlled throughout daily use.
Transport Validation
Cold chain validation must continue beyond warehouse storage and throughout transportation. The MHRA cold chain validation involves the qualification of thermal packaging, validating active and passive cooled systems and checking and recording conditions during transit. Cold chain handover documentation between 3PLs is also necessary to ensure product quality is maintained. The transport validation should be under a qualified responsible person GDP, who should investigate excursions and put into place the corrective actions whenever the distribution conditions are outside the validated limits.
Conclusion
Successful cold chain management requires continuous monitoring, validated equipment, and well-documented distribution processes. A suitable responsible person GDP should be in charge of the temperature monitoring, formation of excursions, and corrective actions. An element of these controls can be achieved through warehouse mapping along with calibrated monitoring devices and transport systems that are validated, which protect the product quality and also meet the GDP & WDA demands.
FAQs
- How long must a seasonal temperature mapping study run in a warehouse?
It should run long enough to capture representative summer and winter temperature conditions across the facility.
- What should a Responsible Person (RP) doimmediatelywhen a cold-chain temperature excursion occurs?
Quarantine affected product, query the excursion, determine the effect on the product, and document the corrective actions taken.
- Are passive insulated shippers sufficient for international cold-chain air freight?
Yes, if they have the correct qualification and validation to sustain these temperatures throughout the duration of the shipment.
