Greetings,
Recently, during an audit, there was a difficulty regarding demonstrating that ‘the temperature was the same throughout the area,’ concerning a small area where a pharmacy with cold chain is located. I understand that such areas do not require thermal mapping due to their relatively small dimensions compared to large warehouses.
What alternatives exist to thermal mapping or how can it be additionally demonstrated besides the use of data-loggers? I have reviewed the technical reports series from WHO 43 and 35 and 1079 USP Chapter, as well as chapters from the pharmacopeia, but they always point to mapping for new areas, not existing ones…
What would you recommend?"