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Run: Capsule In-Process Quality Checks Record

Record in-process capsule quality checks for blending, filling, and packaging, including appearance, moisture, pull test, and brittleness results. Use it to ...

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Inspection Details

Batch / lot number recorded critical (required)

Record the batch or lot identifier for the capsule lot being inspected.

Product name and strength recorded critical (required)

Enter the product name, dosage strength, and capsule size if applicable.

Inspection time and process stage recorded critical (required)

Select the current manufacturing stage when the in-process check was performed.

Note (optional)

Inspector name and signature completed critical (required)

Inspector must sign to confirm the recorded observations and results.

Capsule Appearance and Color Shade

Capsule color shade matches approved standard critical (required)

Assess capsule shell color against the approved master sample or SOP reference.

Capsule surface appearance is uniform and free from visible defects critical (required)

Check for visible defects such as spots, streaks, cracks, dents, or contamination.

Yes No N/A

Printing or imprint legibility verified

Confirm any imprint, logo, or printing is clear, aligned, and legible.

Yes No N/A

Sample photo of capsule appearance captured

Attach a photo of the inspected sample set when required by SOP or batch record.

Moisture and Physical Integrity

Capsule moisture level within specification critical (required)

Record the measured capsule moisture or moisture-related reading per SOP or validated method.

Pull test result meets acceptance criteria critical (required)

Document the capsule pull test outcome used to verify shell integrity or closure performance.

Brittleness observed within acceptable limit critical (required)

Assess capsule brittleness during handling or testing, based on SOP-defined acceptance criteria.

Sampling, Documentation, and Deviations

Sample size and sampling interval followed SOP critical (required)

Record the number of capsules sampled and the defined interval or frequency used for the check.

Reference standard or master sample available at point of inspection

Confirm the approved reference standard used for color shade or appearance comparison was available.

Yes No N/A

Any non-conformance or deviation identified

Indicate whether any result, observation, or trend fell outside specification, SOP, or batch record requirements.

Yes No N/A

Corrective action documented for any failed item

Describe containment, investigation, recheck, or escalation actions taken for any failed check.

QA review completed when required

Confirm QA or supervisor review was completed for any critical item failure or deviation.

Yes No N/A

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