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Run: Empty Hard Capsule Dimensional and Weight QC Inspection

Empty hard capsule dimensional and weight QC inspection template for checking lot identity, controlled measurement conditions, capsule length and diameters, ...

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Inspection Scope and Lot Identification

Capsule type confirmed as empty hard capsules critical (required)

Verify the material being inspected is empty hard capsules and not filled capsules, softgels, or mixed capsule types.

Yes No N/A

Lot number, supplier, and capsule size recorded critical (required)

Record the lot number, supplier name, and stated capsule size designation (e.g., 000 to 5).

Sampling plan documented critical (required)

Document the sampling plan used for the inspection, including sample size and selection method.

Inspection status and date/time recorded

Capture the date and time the inspection was performed.

Reference specification or SOP available at point of use critical (required)

Confirm the applicable capsule specification, drawing, or SOP is available and current for the inspection.

Yes No N/A

Controlled Measurement Conditions

Measurement area clean, dry, and free of contamination critical (required)

Verify the inspection surface and measurement area are clean and free of dust, debris, and product residue that could affect measurements.

Yes No N/A

Temperature and relative humidity within defined limits critical (required)

Record the environmental conditions during measurement and confirm they are within the approved QC limits.

Measuring instruments verified and within calibration critical (required)

Confirm the balance, caliper, micrometer, or other measuring device is calibrated and within its due date.

Yes No N/A

Instrument resolution suitable for capsule measurements

Verify the instrument resolution is appropriate for the capsule size and tolerance being checked.

Yes No N/A

Dimensional Verification

Capsule length measured within specified tolerance critical (required)

Measure the overall capsule length and compare it to the approved specification for the stated capsule size.

Capsule body diameter measured within specified tolerance critical (required)

Measure the body diameter and verify it conforms to the approved dimensional specification.

Capsule cap diameter measured within specified tolerance critical (required)

Measure the cap diameter and verify it conforms to the approved dimensional specification.

Capsule length variation across sample is acceptable

Record the observed spread or variation in capsule length across the sample set.

Weight Verification

Empty capsule unit weight within specified tolerance critical (required)

Measure the weight of empty capsule shells and verify individual units are within the approved weight tolerance.

Weight variation across sample is acceptable critical (required)

Record the observed weight variation across the sample set and confirm it remains within the approved limit.

Capsule weight data reviewed for outliers

Confirm the sample results were reviewed for outliers, trends, or abnormal distribution before release.

Yes No N/A

Appearance, Fit, and Non-Conformance Handling

Capsules free from visible defects affecting fit or function critical (required)

Check for cracks, chips, deformation, split shells, discoloration, or other visible defects that could affect filling or closure.

Yes No N/A

Cap and body fit acceptable critical (required)

Verify the cap and body mate properly and close securely without excessive looseness or interference.

Yes No N/A

Non-conforming capsules segregated and labeled critical (required)

Confirm any rejected capsules were physically segregated, identified, and placed on hold to prevent unintended use.

Yes No N/A

Corrective action or supplier notification initiated when required

Document the corrective action, deviation, or supplier notification initiated for any failed dimensional or weight criteria.

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