Pharmaceutical and FMCG industries often use the words Mapping study and Temperature Qualification study interchangeably. However, there is a slight difference in the scope of work which we explain as below.
Temperature qualification study is a very detailed sequence of tests and analysis. These ensure that the asset is designed and installed in such a way that it is capable of maintaining the desired temperature. After these series of test and verification, the asset is certified to be qualified. This means it is qualified for achieving and maintaining the desired levels of temperature and humidity levels. The various tests under the qualification process, in general, are as under:
In a temperature mapping study, only distribution of temperature & humidity is analyzed. This study makes sure that the distribution is always within the permitted range of temperature and humidity as applicable. However the mapping study does not check various criteria such as SOP, whether the installation has been done correctly, whether the machines are working as per the design, whether written procedures are maintained, whether these written procedures are sufficient etc. All such parameters are covered in a temperature qualification study.
A temperature qualification study includes mapping study, but not vice versa.
If you want to check the only distribution of temperature & humidity, a mapping study is sufficient. If you want to check whether the whole asset is designed, installed and operated correctly, it is desirable to carry out a temperature qualification study.
A qualification study is considered to more of international acceptance. An auditor from another part of the world may not be familiar with the various installation and operational parameters of the asset. If an asset is qualified the asset is considered to be a fully satisfactory system.
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