CoolPac specialists in temperature controlled packaging and temperature monitoring.
We service the pharmaceutical and biomedical industry. CoolPac are experts in cold chain logistics and cold chain packaging. Using CoolPac's proprietary cold chain technology, we have developed pre qualified shipping systems for temperature controlled distribution.
PICS GDP: Section 3.4.5Adequate records of repair, maintenance and calibration activities for key equipment should be made and the results should be retained. Key equipment would include for example: – cold stores, monitored intruder alarm and access control systems, refrigerators, thermo hygrometers, or other temperature and humidity recording devices, air handling units and any equipment used in conjunction with the onward supply chain.”
EU GDP 2013: Section 2.4All personnel involved in wholesale distribution activities should be trained on the requirements of GDP. They should have the appropriate competence and experience prior to commencing their tasks.
EU GDP 2013: Section 2.4Personnel should receive initial and continuing training relevant to their role, based on written procedures and in accordance with a written training program.
SPE GPG: Packing, Labeling and Warehouse FacilitiesMany commercial HVAC (BMS) control systems provide adequate control, data handling, and alarming capability. Such systems should be validated when used for recording critical parameters.
EU GDP 2013: Section 3.3.1
Before a computerised system is brought into use, it should be demonstrated, through appropriate validation or verification studies, that the system is capable of achieving the desired results accurately, consistently and reproducibly.