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QUALIFICATION OF PROCESS EQUIPMENT AND THERMAL MAPPING

 

We stand out for a structured approach based on risk assessment both in the qualification of process equipment and in the thermal mapping of warehouses and storage areas of raw materials and finished products along the entire supply chain.

Our experience, continuous updating and timely organization of activities guarantee an approach that is always in line with regulatory requirements.

If it is relatively easy to re-use the validation protocol of an equipment, there is not guarantee it’s aligned:

    • with the risk analysis that, in line with ICH Q9, starting from the critical quality attributes of the product (CQA - Critical Quality Attributes) allows to identify the critical process parameters (CPP - Critical Process Parameters) specific to each productive unit;
    • with the requirements of the new versions of rules and standards that are issued:
      • 2013 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
      • 2015 UNI EN-285, Sterilization - Steam sterilizers - Large Sterilizers
      • 2015 ANNEX 15, Qualification and Validation. EN Guidelines for GMP for Medicinal Product for Human and Veterinary Use
      • WHO, Technical Report Series No. 961, 2011. ANNEX 9: Model guidance for the storage and transport of time and temperature sensitive pharmaceutical products

 

ENGINEERING CHANGES

Adeodata is able to provide support to companies even in the event of engineering changes: department layout change, new department, equipment change, insertion of a new machinery, change of utilities, movement of equipment with or without modification of the intended use.

 

Support for engineering changes

 

COMPETENCE AND EXPERIENCE

Right here Adeodata makes the difference. Adeodata established the figure of the SME - Subject Matter Expert, a person dedicated to:

    • study the regulations (and related updates);
    • update internal standards, also in light of the experiences on the latest generation of qualified equipment;
    • instruct all consultants on these standards.

The figure of the SME for Adeodata is the basis of the quality system procedures, certified ISO 9001: 2015.

 

INSTRUMENTS

The instrumentation of Adeodata is regularly calibrated. Its software is validated and used in accordance with Data Integrity requirements.

Adeodata S.r.l.
Via E. Mattei, 2

22070 Bregnano (CO)

 

 

Registered office: Via Carducci, 32 — 20123 Milano

VAT Nr. 05617310965    REA 1834791 Milano   PEC adeodata@pec.it

Adeodata SA
Via Calgari, 2

CH 6900 Lugano

IDI CHE-112.203.579

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