SOP Guide for Pharma

SOP for Checking Raw Material Consignment for Transport Damages – V 2.0

Auditor

SOP for Checking Raw Material Consignment for Transport Damages – V 2.0

Standard Operating Procedure for Checking Raw Material Consignment for Transport Damages

Department Supply Chain / Quality Assurance
SOP No. SOP/RM/004/2025
Supersedes SOP/RM/004/2022
Page No. Page 1 of 14
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) defines a structured method for inspecting raw material consignments upon delivery to identify any transport damages that may compromise quality and compliance. Transport damages can manifest in various ways, such as broken seals, dented drums, torn packaging, or moisture ingress, and can result in contamination or spoilage. By implementing a clear protocol for identifying and documenting these damages, the organization ensures that affected materials are either quarantined, returned, or properly handled to minimize risks to product quality and patient safety. A thorough check of transport damages also fulfills regulatory requirements pertaining to traceability and Good Manufacturing Practice (GMP), while promoting accountability and consistent operational standards.

2. Scope

This SOP applies to all raw material deliveries received at the company’s premises, including active pharmaceutical ingredients, excipients, and any other materials used in production. It covers every step from the initial receipt of the consignment, preliminary external inspection, thorough examination of the packaging and containers, quarantine of potentially compromised materials, and final disposition based on the findings. The scope encompasses personnel in Warehouse, Quality Assurance (QA), Quality Control (QC), and relevant support functions such as Procurement and Regulatory Affairs, who may be involved in supplier negotiations or compliance checks.

3. Responsibilities

See also  SOP for Receiving Raw Materials Packed in Drums, Bags, and Carboys - V 2.0

4. Accountability

The Head of Quality Assurance is accountable for enforcing this SOP and ensuring its alignment with current GMP and other regulatory requirements. Final authority in deciding whether to accept, reject, or place a consignment under hold pending further investigation lies with QA Management. The Warehouse Manager bears responsibility for daily implementation and compliance in the receiving area, and any significant deviations or non-conformances should be promptly escalated to the QA Manager.

5. Procedure

5.1 Preliminary Arrangements

Prior to the arrival of raw material consignments, all relevant stakeholders must be prepared to handle and inspect deliveries efficiently.

  1. Documentation Availability
    1. Warehouse personnel ensure that the Purchase Order (PO), shipping documents, and any special handling instructions are readily available for cross-verification.
    2. QA provides updated acceptance criteria or checklist items if any changes have been implemented based on previous transport incidents or new regulatory guidance.
  2. Receiving Area Readiness
    1. Confirm that the receiving dock is clear, well-lit, and that the necessary equipment (forklifts, pallet jacks, temperature loggers) is functional.
    2. Verify that the quarantine zone is labeled and prepared in case materials need immediate segregation due to damage.

5.2 Visual Inspection upon Arrival

When the transport vehicle reaches the facility, a preliminary check is critical to identify glaring anomalies. This step offers an opportunity to detect gross damage or mishandling before offloading.

  1. Vehicle Condition
    1. Inspect the exterior of the transport vehicle for dents, signs of impact, or potential leakage (if it is a container or tanker-type vehicle).
    2. Note any suspicious odors or visible spillage around the loading bay and alert QA immediately if identified.
  2. Document Cross-Check
    1. Match the consignment’s details (number of pallets, boxes, or drums) with the delivery note or packing list. Significant discrepancies must be flagged for QA or Procurement to resolve.
    2. If temperature-controlled transport is specified, check the temperature log data provided by the driver or included with the shipment. Variations outside the acceptable range require immediate QA notification.
  3. Immediate Observations
    1. Record any obvious damage such as torn shrink-wrap, shifted cargo, or spilled contents within the truck.
    2. If the damage appears severe, instruct the driver to wait for QA or an authorized person to assess the situation before offloading. This ensures proper evidence gathering for claims or vendor disputes.

5.3 Detailed Damage Assessment

Once offloading begins, or if the initial inspection shows potential signs of transport damage, a more thorough investigation of individual packages or containers is required.

  1. Offloading Process
    1. Unload each pallet or container carefully to minimize further damage. Use appropriate material handling equipment and follow any special instructions for fragile or hazardous materials.
    2. Place items with suspected damage in a separate, clearly marked area for a closer look. Avoid stacking compromised materials on top of others to prevent cross-contamination or additional breakage.
  2. External Packaging Inspection
    1. Look for dents, holes, punctures, water stains, or signs of mishandling on the secondary and tertiary packaging. This step is crucial for identifying concealed damage that might not be evident during the preliminary check.
    2. Check that sealing tapes, bands, or straps are intact and show no signs of tampering. Broken or replaced seals can indicate unauthorized access or mishandling.
  3. Internal Container Examination
    1. Open a representative sample of boxes or drums—under QA’s guidance—to verify that the primary packaging (e.g., bags, inner liners, pouches) remains secure.
    2. Note any suspicious odor, discoloration, or leaks, which may point to chemical reactions or contact with external contaminants.
    3. If the material is powder-based, check for caking or lumps near potential tear points. For liquids, ensure no wet patches are found on the container walls or packaging inserts.
See also  SOP for Receiving Temperature-Sensitive Raw Materials - V 2.0

5.4 Documentation and Quarantine

Proper record-keeping and immediate segregation of damaged or suspect materials are essential to maintain traceability and prevent accidental usage of potentially compromised raw materials.

  1. Recording Findings
    1. Update the Raw Material Receiving Register (Annexure-1) with specifics regarding the damage: type (e.g., torn packaging, dented drum), extent, and approximate location on the pallet or container.
    2. Take photographs of the damage where feasible, especially for major incidents, and attach these images to the receiving documentation.
  2. Immediate Quarantine
    1. Label compromised materials as “Damaged in Transit” and move them to the quarantine area. Make sure to indicate the date, batch number, and PO number on the quarantine label for clear traceability.
    2. Warehouse personnel should prevent any damaged or questionable items from entering routine warehouse stock areas to avoid cross-contamination or mislabeling.
  3. Communication Protocol
    1. Notify QA and QC about the quarantined materials. Provide relevant documentation (delivery note, pictures, details of damage) so they can assess the severity and potential impact on product quality.
    2. Procurement must also be informed if the damage is significant, frequent, or subject to warranty or liability terms with the shipping company or supplier.

5.5 Communication with Stakeholders

Clear, prompt communication is vital to resolving transport damage issues effectively. Establishing accountability between internal departments and external parties helps expedite corrective actions.

  1. Internal Notification
    1. QA determines if the damaged consignment can be partially salvaged or if it should be fully rejected. If a partial salvage is possible, QC might be directed to perform additional sampling or testing for the intact portion.
    2. Regulatory Affairs may step in if the materials require specific documentation for transport or if the damage involves a regulated substance.
  2. External Communication
    1. Procurement contacts the supplier or carrier to discuss the extent of the damage, share photographic evidence, and request potential replacements or refunds if applicable.
    2. In the event of repeated incidents involving the same shipping company or supplier, a vendor performance review or escalation to management may be warranted to mitigate future occurrences.

See also  SOP for Material Handling in Case of Emergency or Power Failure in Quarantine - V 2.0

5.6 Final Disposition

Based on QA’s evaluation and QC’s testing results, each consignment must be given a final disposition label or status indicating whether it is approved, partially usable, or rejected.

  1. Material Release
    1. If QC analysis confirms that the raw material remains within specification despite minor damage, QA may approve the material for use. A formal release label replaces any quarantine markings, and the stock is moved to the approved storage area.
    2. All relevant documentation must be updated to reflect that the item was initially quarantined, then released with the supporting rationale.
  2. Partial Acceptance
    1. Some shipments might be partially damaged. If QA determines that segregated intact units or containers are unharmed, these can be accepted. The damaged portion, however, is either rejected or requires rework under controlled conditions.
    2. QC logs must clearly identify which sub-batches or container IDs have been approved and which are rejected, maintaining clarity for inventory management.
  3. Rejection and Disposal
    1. If the damage is extensive and cannot be rectified or if the material is found to be out of specification upon testing, the consignment is rejected. Disposal is then conducted per hazardous waste or general waste guidelines, as applicable.
    2. All rejection details, including reason codes and next steps (e.g., return to supplier, incineration, or specialized disposal), must be documented and approved by QA Management. This ensures compliance with local regulations and internal policies.

6. Abbreviations

7. Documents

  1. Raw Material Receiving Register (Annexure-1)
  2. Sampling Log (Annexure-2)

8. References

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 Damage Noted PO Number Remarks
01/02/2025 Global ChemCo API X Batch-101 No PO-55555 None
02/02/2025 Allied Supplies Excipient Y Batch-202 Yes PO-66666 Dented Drums

Annexure-2: Sampling Log

Date Material Name Batch Number Sampling Personnel QC Test Performed Result
02/02/2025 API X Batch-101 Jane Doe Potency, Purity Pass
03/02/2025 Excipient Y Batch-202 John Smith Microbial Limits Fail

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 Established basic protocol for checking transport damages
01/02/2025 2.0 Expanded Procedures Standardization of Document QA Head All All Revised to include more detailed damage assessment steps
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