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.
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.
Compliance and traceability
The goal is not only to produce a physical sample, but to build a controllable system: sample identification, defect classification, supporting documentation and management consistent with the needs of a regulated environment.
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