Capsule In-Process Quality Checks Record

Inspection template for periodic in-process capsule quality checks during blending, filling, and packaging, including color shade, moisture, pull test, and brittleness verification.

Inspection Details

• Batch / lot number recorded
  Record the batch or lot identifier for the capsule lot being inspected.
• Product name and strength recorded
  Enter the product name, dosage strength, and capsule size if applicable.
• Inspection time and process stage recorded
  Select the current manufacturing stage when the in-process check was performed.
• Inspector name and signature completed
  Inspector must sign to confirm the recorded observations and results.

Capsule Appearance and Color Shade

• Capsule color shade matches approved standard
  Assess capsule shell color against the approved master sample or SOP reference.
• Capsule surface appearance is uniform and free from visible defects
  Check for visible defects such as spots, streaks, cracks, dents, or contamination.
• Printing or imprint legibility verified
  Confirm any imprint, logo, or printing is clear, aligned, and legible.
• 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
  Record the measured capsule moisture or moisture-related reading per SOP or validated method.
• Pull test result meets acceptance criteria
  Document the capsule pull test outcome used to verify shell integrity or closure performance.
• Brittleness observed within acceptable limit
  Assess capsule brittleness during handling or testing, based on SOP-defined acceptance criteria.

Sampling, Documentation, and Deviations

• Sample size and sampling interval followed SOP
  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.
• Any non-conformance or deviation identified
  Indicate whether any result, observation, or trend fell outside specification, SOP, or batch record requirements.
• 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.