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QUALIFICATION OF PROCESS EQUIPMENT

 

The qualification of the equipment is probably the activity practiced by the greatest number of institutions of the most varied types (consultants, builders, suppliers, ...). Adeodata stands out for a structured approach based on experience, continuous updating and organization that 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-285Sterilization - Steam sterilizers - Large Sterilizers;
      • 2015 ANNEX 15Qualification and Validation. EN Guidelines for GMP for Medicinal Product for Human and Veterinary Use.

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 Adeodata equipment and related software are used in compliance with the Data Integrity requirements, have been validated and are periodically calibrated.

 

>> Discover our instruments

Adeodata S.r.l.
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