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We are distinguished by a structured risk-based approach to both process equipment qualification and thermal mapping of warehouses/storage areas, for raw materials and finished products, throughout the supply chain. Our experience, continuous updating and timely organization of activities ensure that our approach is always in line with regulatory requirements.

While it is relatively easy to reuse an equipment validation protocol, this may not necessarily be aligned:

  • with the risk analysis: in line with ICH Q9, CPPs - Critical Process Parameters (critical process parameters) specific to each production unit are identified from the CQAs - Critical Quality Attributes (critical product quality attributes);
  • with the requirements of the new versions of the norms and standards that are issued:
    • PDA, Technical Report Series No. 61, Steam in Place (2013)
    • PDA, Technical Report Series No. 3, Validation of Dry Heat Process used for Depyrogenation and Sterilization (2013)
    • UNI EN-285, Sterilization - Steam Sterilizers - Large Sterilizers (2015)
    • EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 15 - Qualification and Validation (2015)
    • WHO, Technical Report Series No. 961, Annex 9 - Model guidance for the storage and transport of time and temperature sensitive pharmaceutical products (2011)


Adeodata's instrumentation is regularly calibrated. Relevant software is validated and is used in accordance with Data Integrity requirements.


Learn more about our instrumentation

Support for engineering changes
Adeodata can provide support to companies in the case of engineering changes: change of department layout, new department, change of equipment, insertion of a new machinery, change of utilities, moving of equipment with or without change of use.


Support for engineering changes

Adeodata S.r.l.
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Adeodata SA
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IDI CHE-112.203.579

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