The importance of Temperature as a critical control parameter for ensuring pharmaceutical quality is recognised by all of the regulatory authorities  e.g  PSI, HPRA, MHRA, FDA. Patient safety is the driver of these regulatory requirements and is the prime concern of the Retail/Community Pharmacy.

Controlled Temperature Storage (“Ambient”)

PSI guidelines require documented temperature (and occasionally humidity) records for the dispensing area used for Pharmaceutical/Medicinal product within label requirements e.g. “do not store over 25ºC/30 ºC/do not freeze

Cold Chain

PSI guidelines require documented temperature records for refrigerators used to store Pharmaceutical/Medicinal product within label requirements e.g. “store between 2ºC and 8 ºC”. The PSI also requires temperature mapping of your pharmacy refrigerator.

We understand that compliance with these regulations adds to your already heavy work load/ list of responsibilities.  We can assist with advice on the solution best suited to your particular business.

This would, typically, comprise:

• Instrumentation (thermo/hygrometer and or temperature/humidity data logger) to monitor temperature/humidity in the various areas
• Calibration services to ensure full compliance
• Temperature Mappping of Pharmacy Refrigerator