Visual Inspection

Visual Inspection (VI) is the final quality gate before any compounded sterile preparation leaves your facility. Every unit must be individually examined against a defined defect library — critically, major, and minor — and the result recorded before the batch can proceed to PIC release. Clarix enforces a two-tier inspection program: a mandatory 100% first-pass inspection of all units, followed by an AQL second-pass statistical sampling based on ANSI/ASQ Z1.4 for batches that pass the first tier.

Role required: Performing visual inspections requires the QA Technician role or higher. Reviewing inspection sessions and overriding automatic determinations requires QA Officer or higher. Final PASS/FAIL approval on a batch requires QA Manager or PIC.

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How visual inspection fits in batch release

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Regulatory and standards basis

The FDA December 2021 guidance on visual inspection of injectable drug products makes clear that a 100% inspection program — not statistical sampling alone — is the expected standard for sterile compounded preparations. AQL second-pass sampling supplements, rather than replaces, the 100% first-pass inspection.

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The two-tier inspection program

Tier 1 — 100% first-pass inspection

Every unit in the batch is individually inspected by a trained inspector. Units are evaluated against the defect library (see below). Each unit receives one of three determinations:

After 100% first-pass is complete, Clarix calculates the reject rate for the batch. A reject rate above your configured threshold triggers an automatic Major deviation.

Tier 2 — AQL second-pass sampling

For batches that pass Tier 1, a statistically determined sample is drawn from the accepted units for a second-pass AQL inspection. Clarix calculates the sample size automatically based on:

• Batch size (number of units)
• Configured AQL level (typically 0.65 for critical defects, 1.0 for major, 4.0 for minor per ANSI/ASQ Z1.4)
• Inspection level (typically General Inspection Level II)

If the number of defects found in the AQL sample exceeds the acceptance number (Ac) for the configured plan, the entire batch is rejected.

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Starting a visual inspection session

1. Navigate to Quality → Visual Inspection in the sidebar.
2. Click New Inspection.
3. Select the Batch to be inspected.
4. Select the Inspection tier: First Pass (100%) or Second Pass (AQL).
5. Confirm the Inspector identity — your facility PIN will be required at completion.
6. For second-pass AQL sessions, Clarix displays the required sample size based on your AQL configuration. Confirm the number of units to be inspected.
7. Click Begin Inspection.

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Inspecting units

For each unit presented during inspection:

1. Select the determination: Accept, Reject, or Reinspect.
2. If Reject, select the defect type from the defect library. You may select multiple defects for a single unit.
3. Use the Notes field to add any clarifying observation (e.g., "particulate in lower third of vial, approximately 1 mm, non-mobile").
4. Advance to the next unit.

Clarix displays a running tally of accepted, rejected, and pending units throughout the session.

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Defect library

The defect library defines every defect category your inspectors evaluate against. Defects are pre-classified by severity:

Critical defects — immediate batch failure

Major defects — investigation required

Minor defects — documented; may not reject unit

Note: Your facility's QA Manager can extend the default defect library by adding custom defect entries in Settings → Quality Configuration. Custom entries must be classified as Critical, Major, or Minor at creation.

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Automatic PASS/FAIL determination

At the conclusion of each inspection session, Clarix calculates the result automatically:

First-pass session:

• PASS — all units inspected; reject rate below configured threshold; no critical defects observed
• FAIL — any critical defect found, or reject rate above threshold; a Major or Critical deviation is automatically opened

Second-pass AQL session:

• PASS — number of defects in sample ≤ acceptance number (Ac) for the configured AQL plan
• FAIL — number of defects in sample ≥ rejection number (Re); batch is placed on hold and a deviation is automatically opened

A batch cannot advance to PIC release until both inspection tiers have recorded a PASS status.

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Inspector qualification

FDA and USP ⟨790⟩ require that visual inspectors be trained and qualified. Clarix links VI results to the inspector's training record. If an inspector's VI qualification is expired or not on file, Clarix will display a warning when they attempt to start an inspection session.

Inspector qualification requirements:

• Initial training on the facility's written VI procedure
• Knapp test or equivalent vision acuity demonstration
• Annual requalification (or per facility SOP)

Configure inspector qualification intervals in Settings → Training Configuration.

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Related pages

• Quality Management System Overview
• Deviations
• QA and PIC Release
• QC Samples
• Protocol Validation