Run Gelatin/HPMC Raw Material Specification and Release Inspection — Free

Receipt and Lot Identification

Material identity matches approved raw material specification critical (required)

Verify the incoming lot is clearly identified as gelatin or HPMC/hypromellose and matches the approved material name, grade, and intended capsule application.

Yes No N/A

Supplier name, lot number, and receiving date recorded critical (required)

Confirm supplier, supplier lot/batch number, internal receiving number, and date received are documented and traceable.

Yes No N/A

Container count and container IDs verified against shipping documents

Check that the number of containers and container identifiers match the bill of lading, packing list, or receiving record.

Yes No N/A

Containers placed in quarantine or controlled hold status critical (required)

Confirm the lot is physically segregated and not available for production use until QA release is completed.

Yes No N/A

Documentation and Supplier Certification

Certificate of Analysis received for each lot critical (required)

Verify a current Certificate of Analysis is available for the specific lot under review.

Yes No N/A

Certificate of Analysis includes viscosity result and test method critical (required)

Confirm the CoA reports viscosity, the test method used, and the reported result for the lot.

Yes No N/A

Certificate of Analysis includes gel strength or bloom value where applicable critical (required)

For gelatin lots, confirm bloom/gel strength is reported with the associated test method and result.

Yes No N/A

Microbial limits results are included and within specification critical (required)

Verify the supplier documentation includes microbial limit testing results and that reported values meet the approved specification.

Yes No N/A

Specification revision matches approved internal standard

Confirm the supplier documentation references the current approved internal or customer specification revision for the material.

Yes No N/A

Physical Condition and Packaging Integrity

Outer packaging intact with no tears, punctures, or water damage critical (required)

Inspect all sampled containers for visible damage, moisture intrusion, or compromised packaging that could affect material quality.

Yes No N/A

Photo evidence (optional)

Container seals and closures intact critical (required)

Verify seals, liners, tamper evidence, and closures are intact and show no signs of opening or leakage.

Yes No N/A

Photo evidence (optional)

No visible foreign matter or contamination observed critical (required)

Check for dust, debris, odor anomalies, discoloration, or other signs of contamination during receiving inspection.

Yes No N/A

Storage conditions at receipt acceptable for material type

Confirm the receiving area conditions and immediate storage conditions are suitable for gelatin or HPMC material and do not expose the lot to moisture or heat beyond site limits.

Yes No N/A

Incoming Test Results Review

Viscosity result recorded and within acceptable range critical (required)

Enter the measured viscosity or review the supplier-reported viscosity result and confirm it meets the approved specification for the material grade.

Gel strength / bloom value recorded and within acceptable range critical (required)

For gelatin lots, record the bloom value or gel strength result and confirm it meets the approved specification.

Microbial limits meet specification critical (required)

Confirm the lot meets the approved microbial limits specification, including any required bioburden or indicator organism criteria.

Yes No N/A

Test methods are approved and current

Verify the viscosity, bloom/gel strength, and microbial methods used are approved, current, and appropriate for the material type.

Yes No N/A

Any out-of-specification or atypical result documented critical (required)

Confirm any atypical, borderline, or failed result has been documented and escalated per site procedure.

Yes No N/A

Release Decision and Disposition

QA disposition recorded critical (required)

Select the final disposition for the lot after review of documentation, inspection, and test results.

Material released only after all critical criteria passed critical (required)

Confirm the lot is not released unless all critical items in this inspection have passed and required documentation is complete.

Yes No N/A

Release authorization completed by QA or designated approver critical (required)

Verify the final release is authorized by QA or another designated approver per site procedure.

Release date and time recorded

Record the date and time the lot was formally released or placed on hold/rejected.

Comments and corrective actions documented for any deficiency

Summarize any deficiency, non-conformance, or corrective action required before final disposition.

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Run: Gelatin/HPMC Raw Material Specification and Release Inspection

Receipt and Lot Identification

Documentation and Supplier Certification

Physical Condition and Packaging Integrity

Incoming Test Results Review

Release Decision and Disposition

Get your results