SOP for Checking Seal Integrity on Raw Material Drums and Containers – V 2.0

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SOP for Checking Seal Integrity on Raw Material Drums and Containers – V 2.0

Standard Operating Procedure for Checking Seal Integrity on Raw Material Drums and Containers

Department Warehouse / Quality Assurance / Procurement
SOP No. SOP/RM/028/2025
Supersedes SOP/RM/028/2022
Page No. Page 1 of 15
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) defines a clear and consistent method for verifying the seal integrity of raw material drums and containers during receiving and initial inspection. Properly sealed containers are crucial in preventing contamination, maintaining the potency of active and inactive substances, and preserving product stability. By carefully checking seal integrity upon arrival, the organization:

  • Identifies compromised packaging early, preventing use of potentially adulterated or deteriorated materials.
  • Ensures Good Manufacturing Practice (GMP) compliance and product quality from the very start of the supply chain process.
  • Facilitates quick communication with suppliers if repeated seal failures occur, reducing further production delays.
  • Minimizes safety hazards caused by leaks of hazardous or temperature-sensitive compounds.

Proper seal checks form a critical component of raw material receiving and documentation, helping maintain high standards of product quality and regulatory compliance.

2. Scope

This SOP applies to all incoming raw materials delivered in sealed drums or containers, including (but not limited to) metal drums, plastic drums, carboys, and specialized sealed vessels for hazardous or sensitive substances. It includes:

  • Procedures for visual and physical seal checks at the time of receipt.
  • Documentation of seal-related findings in the Raw Material Receiving Register.
  • Criteria for seal acceptance or failure and subsequent actions (e.g., quarantine, rejection).
  • Communication with Quality Assurance (QA), Procurement, and other relevant departments for resolving seal integrity issues.

Warehouse personnel, QA, Quality Control (QC), and Procurement staff must follow these guidelines upon receipt of any sealed drum or container, ensuring consistency and GMP alignment.

3. Responsibilities

  • Warehouse Personnel:

    • Inspect each drum or container upon arrival, focusing on seal presence, condition, and proper labeling.
    • Document any compromised or missing seals and alert QA of potential contamination risks or shipping damages.
    • Place suspect or unsealed items in a designated area (quarantine or holding zone) pending QA decision.
    • Complete entries in the Raw Material Receiving Register (Annexure-1) with accurate notes on seal integrity and drum condition.
  • Quality Assurance (QA) Team:

    • Define standards for acceptable seal types (e.g., tamper-evident, crimped lids) and set criteria for acceptance or rejection based on seal integrity.
    • Make final decisions on quarantining or rejecting materials with questionable or missing seals.
    • Oversee any non-conformance or deviation records if repeated or significant seal failures occur from a particular supplier.
    • Authorize movement from the holding area to official quarantine or disposal once the seal check is complete.
  • Quality Control (QC) Team:

    • Perform additional checks or sampling if QA deems the compromised seal to pose a contamination risk, requiring lab analyses to confirm product integrity.
    • Share results with QA to finalize acceptance or rejection, especially if there are chemical or microbial concerns from a suspected broken seal.
  • Procurement Department:

    • Ensure that POs reference appropriate packaging and sealing requirements for all raw materials, especially for sensitive or hazardous chemicals.
    • Liaise with suppliers if consistent or major seal integrity issues arise, negotiating returns, credits, or corrective actions to prevent repeated incidents.

4. Accountability

The Warehouse Manager ensures consistent application of this SOP, verifying that drum seals and container integrity checks align with GMP standards. The QA Manager holds the ultimate authority to accept, quarantine, or reject materials based on seal inspection outcomes or subsequent test results. Changes to this SOP must be approved by QA management to maintain compliance with regulatory and internal policies.

5. Procedure

5.1 Pre-Receipt Preparations

Adequate planning and training minimize confusion during inspections and ensure seal integrity is a routine check in the receiving process.

See also  SOP for Weighing and Cross-Verification of Received Materials - V 2.0

  1. Documentation and PO Review

    1. Procurement provides the Warehouse with the Purchase Order (PO) specifying the product name, batch number, quantity, and sealing requirements if any (e.g., tamper-evident seals, crimped lids, specialized container closures).
    2. Verify that any known special instructions—such as color-coded tamper tags or barcoded seals—are documented. Warehouse staff should be aware of these details before shipments arrive to identify potential discrepancies quickly.
  2. Training and Tools

    1. Warehouse Personnel must be trained to recognize normal vs. compromised seal conditions. Provide reference materials or images illustrating correct seal shapes, security tags, or crimping patterns to help staff identify damage or tampering.
    2. Ensure labeling supplies (e.g., “Hold” stickers) and basic tools (flashlights, magnifying glass if needed) are available to check small cracks, scuffs, or unauthorized re-seals. If some seals have serial numbers or barcodes, ensure the staff can scan or manually compare them with shipping documents.
  3. Space and Equipment Readiness

    1. Prepare a clean receiving area large enough to inspect drum or container seals thoroughly without rushing. Separate zones for different POs help avoid mixing or mislabeling.
    2. Check forklift trucks, drum dollies, or other handling devices for safety and functionality. This prevents accidental seal damage during the inspection or offloading process.

5.2 Unloading and Preliminary Inspection

Once the shipment arrives, Warehouse Personnel unload containers carefully, ensuring no further damage to seals occurs, then perform an initial visual inspection.

  1. Safe Handling

    1. Unload drums or containers with appropriate equipment, avoiding collisions or forceful impacts that might crack or break seals. Keep them upright if they contain liquids to reduce spillage risk and maintain normal seal orientation.
    2. Place containers in the designated receiving area or holding zone, grouping each batch or line item from the PO. Do not stack or cluster them in a way that obscures the seal or container top/lid.
  2. Basic Seal Check

    1. Examine the top and sides of each drum or container, verifying that the seal is intact, unbroken, and correctly seated. Look for gaps between lids and container rims, missing security tags, or signs of adhesives or tape that differ from standard supplier practices.
    2. Note if the container appears to have been re-sealed or if official tamper-evident tape is partially peeled off. If so, flag it as “Suspect—Seal Issue” in the receiving log for QA’s attention.
  3. Cross-Referencing Seals with Documents

    1. If the PO or supplier documents mention specific seal numbers or barcodes, ensure the actual container seal matches. Any mismatch or absence of a listed seal ID triggers immediate isolation of that container in a “Hold” area until QA is notified.
    2. Record each container’s seal status in the Raw Material Receiving Register if it’s a standard practice to track seal ID or condition. Indicate “Seal Intact,” “Seal Missing,” “Seal Damaged,” etc.

5.3 Labeling and Temporary Storage

After verifying the seal, items remain in a temporary holding area or go directly to quarantine, depending on the facility’s receiving workflow.

  1. Marking and Logging

    1. If all seals are intact with no visible anomalies, label each drum or container “Hold—Seal OK,” referencing the PO and batch number. Log each container in Annexure-1 with remarks like “Seal Intact.”
    2. For suspicious or broken seals, label them “Hold—Seal Issue” and move them to a segregated spot in the holding area or quarantine. Note the container ID or batch number and describe the seal problem (e.g., “Cracked ring,” “Tampered tape,” “Partial re-seal”).
  2. Short-Term Holding

    1. Keep containers with questionable seals physically distant from those with verified seals to avoid confusion. This separation aids QA or QC in quick identification if they want to inspect or sample suspect containers first.
    2. Ensure temperature or hazard requirements are still followed. If a drum is flammable or requires cold storage, place it in an appropriate environment but keep “Hold” labels visible for staff awareness.

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5.4 QA Evaluation and Potential Sampling

Quality Assurance decides how to handle containers with intact seals (which may proceed to standard quarantine) versus those with seal anomalies that might warrant deeper investigation or direct rejection.

  1. Review of Seal Condition

    1. QA reviews the Warehouse’s notes on each drum or container’s seal status. If they confirm an intact seal and correct labeling, QA may authorize normal quarantine or immediate usage if the site uses skip-lot testing or a risk-based approach (for known suppliers).
    2. For questionable seals, QA inspects the container in person or requests pictures to ascertain if minor scuffs are acceptable or if the seal truly indicates tampering or a manufacturing defect.
  2. Sampling and QC Tests

    1. If QA suspects any product integrity breach, QC collects a sample according to SOPs (Annexure-2) to test identity, purity, or microbial content, ensuring that no hidden adulteration occurred through the compromised seal.
    2. QC test outcomes determine if the material is quarantined further, re-labeled, or outright rejected. This approach mitigates contamination risk for critical raw materials used in direct product contact or sterile manufacturing.

5.5 Acceptance, Quarantine, or Rejection Based on Seal Status

The final fate of a drum or container depends on QA’s assessment and any test results, ensuring only properly sealed materials proceed to production.

  1. Drums/Containers with Intact Seals

    1. If QA confirms the seal is intact and all other acceptance criteria (correct labeling, matching PO, optional CoA checks) are met, the batch is cleared to proceed. The Warehouse re-labels the container for “Quarantine” or “Approved Storage,” as standard procedure dictates.
    2. Record the updated status in the receiving log or WMS, noting the final location. Commonly, containers remain quarantined until final QC or skip-lot tests confirm product quality.
  2. Drums/Containers with Compromised Seals

    1. Minor Damage, Possibly Salvageable: In rare cases, a slightly bent or scuffed seal might still preserve container integrity. QA may allow re-sealing or close monitoring if no risk of adulteration is found. Document the corrective action in the receiving register and attach a “Rework” label if re-sealing under controlled conditions is feasible.
    2. Severe Damage, High Risk: If the seal is obviously tampered with or broken, or if QC tests confirm contamination, QA instructs the Warehouse to move the container to “Rejected” storage. The reason is documented (“Seal Tampering, Potential Adulteration”). Procurement manages return or disposal with the supplier.
    3. Pending Clarification from Supplier: If the container came with an atypical or non-standard seal type not listed in the PO, QA or Procurement might contact the supplier for verification. Meanwhile, the container stays “On Hold” in the holding area or quarantine until a conclusive decision is made.

5.6 Record-Keeping and Supplier Communication

Thorough, transparent records support GMP compliance and expedite supplier resolution if repeated seal failures occur.

  1. Raw Material Receiving Register Completion

    1. Warehouse Personnel finalize register entries (Annexure-1) with details like “Seal OK—Moved to Quarantine” or “Seal Broken—Rejected” under “Remarks.” Sign or initial each line for accountability.
    2. Attach or cross-reference any CoAs, supplier seal documentation, or deviation records if the lot needed further investigation.
  2. Sampling Log (If Applicable)

    1. QC staff fill out Annexure-2 with sampling date, type of test performed, and results. Notes or references to “Compromised Seal Investigation” can be included in the “Remarks” column.
    2. Any test results leading to rejection or acceptance must be accessible to QA when finalizing the batch’s official status.
  3. Deviation or Non-Conformance Handling

    1. If repeated seal issues surface from the same supplier, QA or Warehouse opens a deviation report. Summaries of each event feed into improvement plans or require the supplier to propose new sealing protocols.
    2. Procurement and QA may revise the Approved Vendor List (AVL) status if the vendor fails to implement corrective and preventive measures. Document each step in the facility’s quality management system.
  4. Supplier Feedback and Credits

    1. If a shipment is partially or fully rejected due to compromised seals, Procurement negotiates replacements or refunds. Keep records of email or phone logs with the supplier. A consistent pattern of blame or denial from the vendor might prompt a deeper audit.
    2. For minor seal mishaps quickly resolved by the supplier, indicate the fix in the batch record (e.g., new container shipped, re-seal kit provided) and confirm QA’s final acceptance once it’s done properly.
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5.7 Continuous Improvement and Periodic Audit

Seal integrity checks can evolve over time based on new container designs, advanced tamper-evident technologies, or updated supplier agreements.

  1. Reviewing Seal Data Trends

    1. QA or Warehouse managers periodically examine seal-related incidents (e.g., how many shipments had broken or questionable seals, from which suppliers). This data can guide training updates or negotiation with consistently failing suppliers.
    2. Implement CAPA if there are recurring internal handling mistakes or forklift accidents known to crack container lids or cause ring deformations. This fosters a safer, more reliable receiving process over the long term.
  2. Regulatory and Supplier Audits

    1. During internal or external GMP audits, be prepared to demonstrate how the facility checks container seals and addresses suspected tampering. Show relevant logs, training records, and documented outcomes of any deviations or non-conformance reports.
    2. Procurement or QA can incorporate seal integrity items into routine supplier audits, verifying that the vendor’s packaging line maintains consistent crimping pressures, ring locks, or tamper-evident tape usage as claimed.
  3. Periodic SOP Revisions

    1. As new container technologies emerge (e.g., RFID-enabled locks, advanced plastic liners), update this SOP to instruct staff on verifying these new seal types or reading scanning data. Provide images or references in the annexures if needed to help them identify common issues with new seals.
    2. Reflect feedback from staff or external audits about unclear steps or missed scenarios. All changes require QA approval and re-training as necessary.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • PO: Purchase Order
  • CoA: Certificate of Analysis
  • CAPA: Corrective and Preventive Action
  • AVL: Approved Vendor List
  • RFID: Radio-Frequency Identification
  • WMS: Warehouse Management System
  • ERP: Enterprise Resource Planning

7. Documents

  1. Raw Material Receiving Register (Annexure-1)
  2. Sampling Log (Annexure-2) if testing is needed
  3. Purchase Orders (PO), Supplier Invoices, Packing Lists
  4. Certificates of Analysis (CoAs) and Tamper-Evident Documentation (if applicable)
  5. Deviation / Non-Conformance Reports (if required)

8. References

  • 21 CFR Part 211 – Current GMP for Finished Pharmaceuticals (US FDA)
  • EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
  • ICH Q7 – GMP for Active Pharmaceutical Ingredients
  • Company-Specific Procurement, Warehouse, QA Policies
  • AVL Documentation and Supplier Sealing Protocols

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Raw Material Receiving Register

Date Supplier Name Material Name Batch Number PO Number Quantity Seal Condition Remarks
01/02/2025 ABC Distributors API-X X-2025-001 PO-111111 100 kg Intact Labels Correct, Moved to Quarantine
02/02/2025 XYZ Chemicals Excipient-Y Y-2025-ABC PO-222222 200 kg Broken Suspicious Seal, QA Review

Annexure-2: Sampling Log

Date Material Name Batch Number Sampling Personnel QC Test Performed Result Remarks
01/02/2025 API-X X-2025-001 John Doe Identity, Assay Pass Seal Confirmed Intact, No Contamination
02/02/2025 Excipient-Y Y-2025-ABC Jane Smith Microbial Limit Pending Seal Broken, Under Investigation

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By Page No. Ref. Point No. Details of Revision
01/01/2024 1.0 Initial Version New SOP Creation QA Head All All Defined procedure for verifying seal integrity
01/02/2025 2.0 Expanded Seal Checks Standardization of Document QA Head All All Added guidance on tamper-evident tape, barcoded seals, and rework scenarios for minor seal issues
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