MGC Life Science

Mapping and thermal qualification of areas

The main need for thermal mapping of areas, combined with international Good Storage Practices and Good Manufacturing Practices (GDP), is to verify the homogeneity and thermal stability of the environment through temperature records and, based on these records, identify the most critical, hottest, and coldest points, thus facilitating decision-making regarding routine monitoring and aiding in structural adjustments.

The thermal study must be carried out in accordance with applicable regulations: 

  • ANVISA – RDC No. 430, of October 8, 2020 – Provides for Good Distribution, Storage and Transportation Practices for Medicines; 
  • USP 36 [1079] Good Storage and Shipping Practices/General Information; 
  • WHO Technical Report Series, No. 961, 2011; 
  • FDA Regulation 21 CFR Part 11. 

Key points to be respected for the study include: 

  • Number of points to be monitored, respecting the distance between points as described in USP 36; 
  • Study time: Generally 7 days; 
  • Use of devices (Data loggers) in accordance with 21 CFR Part 11 (inviolability of data); 
  • Study periodicity: 1 year (being carried out in at least two seasons (summer and winter), depending on the region). 

 

Climatic conditions can have a direct impact on the results, therefore it is recommended that the thermal mapping study be carried out in the most critical seasons of the year, with one thermal mapping in summer and one thermal mapping in winter. 

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