Monitoring Manufacture, Storage and Distribution environments in the Pharmaceutical Industry

MHRA guidelines advise that the manufacture, storage and distribution stages of pharmaceutical products are monitored to ensure that any facilities involved meet the required standards. Of the various parameters that need to be carefully controlled, temperature and humidity are perhaps the two most critical.

All parties involved in the manufacture, storage and distribution of pharmaceutical products are required to record and keep details of temperatures during these processes. Where these records are collected electronically, then 21 CFR Part 11 also applies, which aims to give electronic records and signatures the same weight and trustworthiness as their paper-based counterparts. A key aspect of 21 CFR Part 11 is its focus on security, particularly relating to the prevention of data tampering and the ability to identify specific individuals and events involved in the production and / or data management processes.