Mahant Pharma Advances
A validated reference set with known defects is used for training, qualification, and verifying visual inspection systems in pharmaceutical manufacturing.
A method to review visual inspection capabilities by presenting defect samples to assess sensitivity and agreement.
A structured training and qualification approach that standardizes visual inspection using defect libraries.
It is conducted using a validated Knapp Kit in a controlled inspection environment, with recorded responses to assess detection rates.
Periodic verification of a Knapp Kit’s integrity, ensuring defect samples remain usable for training and system challenges.
The standard operating procedure for performing defect detection exercises using Knapp Kits is in line with USP
A set of pharmaceutical containers with known visual defects, used for training and ongoing performance monitoring.
The analysis of finished products for visible defects before release, ensuring patient safety and legal guidelines.
Vials are checked for particulates, cracks, and closure integrity under controlled lighting, with documentation as per SOP.
The examination of raw materials for contaminants or discoloration before formulation, ensuring GMP agreement.
Criteria defining acceptable and unacceptable defects, detection methods, and inspection frequency, set by official bodies.
ISO-compliant lighting, inspection booths, magnification devices, Knapp Kits, and qualified personnel.
Trained personnel, validated environments, defect libraries, and periodic performance monitoring.
A document outlining inspection parameters, standardizing activities and supporting traceability.
Not always; human factors and defect types can affect detection, but USP <1790> emphasizes improving detection with POD studies.
Typically 30–50 cm from the eyes, with 5–10 seconds per container under standardized lighting.
