Qualification & validation
Qualification and validation, AFP smoke study, thermal requalification. GAMP5, Annex 11, 21 CFR Part 11 compliance.
Visual inspection
Defect kits for GMP visual inspection
We design and build defect kits (visual inspection test sets / seeded defects) intended for testing and qualification/validation of GMP equipment for Automatic Visual Inspection (AVI), with cosmetic and particulate defects reproduced using certified instrumentation. Every kit has a unique ID and a certificate issued with Avera, our proprietary software designed around ALCOA+ principles.
What they are for
Defect kits standardize defect recognition on vials, bottles and pharmaceutical containers and support the testing and qualification/validation of Automatic Visual Inspection (AVI) equipment, as well as operator training and periodic challenge sets for visual inspection.
Cosmetic and particulate defects
We reproduce representative cosmetic and particulate defects with certified instrumentation: laser marking, microscopy with certified slides and inspection stations to produce, document and verify samples in a repeatable way.
Regulatory references
We design the sets in line with the main visual inspection references: USP <1790> (United States Pharmacopeia), Ph. Eur. 2.9.20 (European Pharmacopoeia) and PDA Technical Report No. 34 and 79.
Certificates issued with Avera, proprietary ALCOA+ software
Every kit and every seeded sample has a unique ID. The certificate is issued by Avera, the software developed in-house by Eurosystem and designed around ALCOA+ principles: for each defect it records type, class, size, production method and the instrument used together with its calibration status, keeps an audit trail of changes and involves two distinct, tracked steps (performer and approver), each bound to the authenticated user with date and time. The result is a document that is attributable, legible, contemporaneous, original and accurate, ready for the AVI qualification dossier.
Life cycle and re-certification
A kit is not a static object: it is used in periodic challenge sets and samples can deteriorate. Avera manages certificate revisions and periodic re-certification (typically yearly): each revision states the reason, the re-verified samples and the instruments used, and formally supersedes the previous one, which remains available in the history.
Frequently asked questions
What documentation comes with a Eurosystem defect kit?
A certificate of conformity issued with Avera listing every seeded sample with its unique ID, category (cosmetic or particulate), defect class, size, production method and the instrument used with its calibration status, plus the verification outcome, regulatory references (USP <1790>, Ph. Eur. 2.9.20, PDA TR 34 and 79) and the identification of performer and approver.
What is Avera?
Avera is Eurosystem's proprietary software for managing defect kits and issuing their certificates. It is designed around ALCOA+ principles: unique IDs for kits and samples, audit trail of changes, segregation of duties between performer and approver, and management of certificate revisions.
Who verifies and who approves the certificate?
The certificate goes through two distinct users: the one who produced and verified the samples (production) and the one who approves and issues it (QA). The system enforces segregation of duties and records who, when and with which meaning (verified or issued) in the audit trail.
Does the kit need re-certification? How often?
Yes. Seeded samples can deteriorate with use, so the kit is re-verified periodically, typically every 12 months or after events that call its integrity into question. Avera issues a new revision of the certificate with the reason for revision and the re-verified samples; the previous revision remains in the history.
How do you ensure the traceability of the instruments used to produce the defects?
Laser marking, microscope and reference slides are calibrated or certified by accredited laboratories, and every kit certificate lists the instruments used with certificate number and expiry date as they were at the time of issue.
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