Gelatin/HPMC Raw Material Specification and Release Inspection

Verifies incoming gelatin and HPMC (hypromellose) raw materials meet specification for viscosity, gel strength/bloom, microbial limits, documentation, and release prior to capsule manufacturing use.

Receipt and Lot Identification

• Material identity matches approved raw material specification
  Verify the incoming lot is clearly identified as gelatin or HPMC/hypromellose and matches the approved material name, grade, and intended capsule application.
• Supplier name, lot number, and receiving date recorded
  Confirm supplier, supplier lot/batch number, internal receiving number, and date received are documented and traceable.
• 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.
• Containers placed in quarantine or controlled hold status
  Confirm the lot is physically segregated and not available for production use until QA release is completed.

Documentation and Supplier Certification

• Certificate of Analysis received for each lot
  Verify a current Certificate of Analysis is available for the specific lot under review.
• Certificate of Analysis includes viscosity result and test method
  Confirm the CoA reports viscosity, the test method used, and the reported result for the lot.
• Certificate of Analysis includes gel strength or bloom value where applicable
  For gelatin lots, confirm bloom/gel strength is reported with the associated test method and result.
• Microbial limits results are included and within specification
  Verify the supplier documentation includes microbial limit testing results and that reported values meet the approved specification.
• Specification revision matches approved internal standard
  Confirm the supplier documentation references the current approved internal or customer specification revision for the material.

Physical Condition and Packaging Integrity

• Outer packaging intact with no tears, punctures, or water damage
  Inspect all sampled containers for visible damage, moisture intrusion, or compromised packaging that could affect material quality.
• Container seals and closures intact
  Verify seals, liners, tamper evidence, and closures are intact and show no signs of opening or leakage.
• No visible foreign matter or contamination observed
  Check for dust, debris, odor anomalies, discoloration, or other signs of contamination during receiving inspection.
• 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.

Incoming Test Results Review

• Viscosity result recorded and within acceptable range
  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
  For gelatin lots, record the bloom value or gel strength result and confirm it meets the approved specification.
• Microbial limits meet specification
  Confirm the lot meets the approved microbial limits specification, including any required bioburden or indicator organism criteria.
• 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.
• Any out-of-specification or atypical result documented
  Confirm any atypical, borderline, or failed result has been documented and escalated per site procedure.

Release Decision and Disposition

• QA disposition recorded
  Select the final disposition for the lot after review of documentation, inspection, and test results.
• Material released only after all critical criteria passed
  Confirm the lot is not released unless all critical items in this inspection have passed and required documentation is complete.
• Release authorization completed by QA or designated approver
  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.