What Is the Difference Between Critical, Major and Minor Defects in Injectables?

Critical, major and minor defects in pharma injectables explained with vial, ampoule and PFS examples, USP AQL ranges and a risk-based method.

Critical, major and minor defects in pharma injectables are three risk classes used to sort defects found during the visual inspection of vials, ampoules, prefilled syringes and cartridges. A critical defect can harm the patient or break sterility, such as a cracked vial. A major defect affects function, dose or usability, such as underfill. A minor defect is cosmetic only, such as a light scratch on the outer glass.

The class you assign decides the AQL limit, how many defects are allowed in the QA sample, and whether the batch can be released.

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