Temperature Monitoring Regulations for Pharmaceuticals
National and international organizations regularly share findings and best practices in order to provide the public with safe drugs. GxP, or good (“x” denotes an industry) practice, is an international term. GMP, good manufacturing practices, and GDP, good distribution practices, are most well known in the pharmaceutical industry for providing a standard in which to follow.
GxP Compliant Monitoring
These articles will give you an overview and details of GxP for the pharmaceutical industry so you can get your process up-to-speed.
GMP and GDP are documented in the Food and Drug Administration (FDA), European Union (EU), Parental Drug Association (PDA), ISPE, World Health Organization (WHO), International Society for Pharmaceutical Engineering (USP), or International Council for Harmonisation (ICH).
The US requires adherence to the Code of Federal Regulations 21 (FDA) Part 11. (CFR 21 Part 11). The regulation explains the requirement of electronic records in order to prove pharmaceutical products are stored according to their established conditions. If, however, the drugs were exposed to unfavorable conditions, the drug should either be destroyed or returned to the supplier for investigation (CFR 21 Part 205).
In summary: wherever warehouses are located, they are subject to rigorous local and global standards. Warehouse mapping, that is the qualification and mapping of storage rooms and areas, is essential for the compliance of all GxP storage facilities.
WHO guidelines are specific to vaccine classes and their allotted temperature ranges within a 48 hours timespan. The WHO dictates the criteria required for temperature monitoring devices that should be in all shipments. It requires vaccines be stored in temperature-controlled environments through the entirety of the shipment.
WHO also recommends 50% RH and manufacturing temperature ranges. A relative humidity below 45% can cause medicines to dry out, while a relative humidity over 60% can change drug characteristics and create conditions for bacteria, viruses, bacteria, mold and fungus.
GMP Regulations: Your Product and Process Quality Control Responsibilities
An easy-to-follow guide to help readers understand GMP.