SOP for Inspection of Double-Checked and Double-Bagged Raw Materials – V 2.0

Posted on By Auditor

SOP for Inspection of Double-Checked and Double-Bagged Raw Materials – V 2.0

Standard Operating Procedure for Inspection of Double-Checked and Double-Bagged Raw Materials

Department Warehouse / Quality Assurance / Quality Control
SOP No. SOP/RM/020/2025
Supersedes SOP/RM/020/2022
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) provides the method for inspecting raw materials that arrive with double-checked packaging and are double-bagged. Double-checked packaging typically signifies an additional layer of quality control performed by the supplier or an intermediary, while double-bagging offers extra protection against contamination, moisture, or damage. This SOP ensures that:

  • All double-bagged materials are inspected thoroughly to verify the integrity of both the outer and inner bags.
  • The supplier’s double-check and associated documents are confirmed to match the material identity, batch number, and quantity expected.
  • Any discrepancies or damages discovered are properly documented and communicated to Quality Assurance (QA) and Procurement.

By following these guidelines, the organization upholds Good Manufacturing Practice (GMP) requirements, minimizes contamination risks, and maintains a reliable material supply for further processing or production.

2. Scope

This SOP applies to all double-checked and double-bagged raw materials delivered to the facility’s receiving dock or warehouse, including active pharmaceutical ingredients (APIs), excipients, intermediates, and other items requiring enhanced packaging. The procedure covers:

  • Pre-receipt preparations (documentation, area readiness, PPE requirements).
  • Inspecting both outer and inner bags for damage, tampering, or contamination.
  • Verifying double-check documentation (e.g., special seals, supplier quality certificates) against Purchase Orders (PO) and supplier documents.
  • Recording inspection findings and managing any deviations (e.g., damaged or mislabeled batches).

Warehouse Personnel, Quality Assurance (QA), and Quality Control (QC) staff must follow these steps to ensure the integrity and accuracy of double-bagged shipments. Procurement may also consult this SOP if supplier-related issues or documentation discrepancies occur.

3. Responsibilities

  • Warehouse Personnel:

    • Unload and arrange double-bagged shipments in a designated inspection area.
    • Visually inspect both outer and inner bags for damage, correct labeling, and tampering.
    • Match received materials against the PO and supplier’s double-check certificates or documentation.
    • Document observations and discrepancies in the Raw Material Receiving Register (Annexure-1).
    • Coordinate with QA if packaging integrity is compromised or if labeling does not match the PO.
  • Quality Assurance (QA) Team:

    • Review the inspection criteria for double-bagged materials, ensuring compliance with GMP and internal quality standards.
    • Approve or reject shipments with suspect outer or inner bag damage, labeling errors, or incomplete double-check documentation.
    • Lead deviation or non-conformance investigations related to damaged or mismatched double-bagged materials.
    • Authorize final release or rejection once all checks are completed and necessary sampling (if any) is done.
  • Quality Control (QC) Team:

    • Conduct sampling if QA or internal SOPs require immediate checks to confirm material identity, purity, or safety.
    • Notify QA of any anomalies discovered during preliminary tests that suggest contamination or labeling mismatch.
  • Procurement Department (If Applicable):

    • Ensure the PO specifies that materials must be double-checked and double-bagged where necessary (e.g., for high-sensitivity or GMP-critical raw materials).
    • Address supplier-related issues if repeated or major discrepancies emerge regarding double-check seals or bag integrity.

4. Accountability

The Warehouse Manager is accountable for correctly applying this SOP during the receipt of double-bagged materials. The QA Manager has final authority to accept or reject shipments based on inspection findings and must be informed of any significant deviations. Any changes to this SOP must be reviewed and approved by QA Management to maintain compliance with GMP and organizational policies.

See also  SOP for Sampling at Receiving Stage for Preliminary Inspection - V 2.0

5. Procedure

5.1 Pre-Receipt Preparations

Adequate readiness ensures an efficient, standardized inspection of double-bagged materials, mitigating contamination or material mix-up risks.

  1. Documentation Review

    1. Procurement provides the Warehouse with the final PO, specifying the material name, batch number, quantity, and any additional instructions about double-check or double-bagging requirements.
    2. Ensure all relevant supplier documentation is available (e.g., packing list, supplier quality certificate indicating double-check procedures, CoA if available).
  2. Inspection Area Readiness

    1. Designate a clean, unobstructed area for unloading and inspecting double-bagged materials. If needed, use a raised platform or specialized table to carefully check bag surfaces.
    2. Gather necessary PPE (e.g., gloves, lab coat, safety glasses) and inspection tools (flashlight, camera for documentation) as required by internal SOPs or safety guidelines.

5.2 Receiving the Shipment

After the shipment arrives, Warehouse Personnel unload the materials, checking for any obvious external damage or anomalies.

  1. Unloading Procedure

    1. Use forklifts or pallet jacks to unload the pallets or containers containing the double-bagged materials. Stack or arrange them carefully to prevent tears or punctures in the outer bag.
    2. Check for spilled product, torn shrink-wrap, or any sign that the packaging was tampered with during transit. If discovered, label those items “Suspect” and segregate them for QA to decide next steps.
  2. Document Cross-Check

    1. Compare the PO details (item name, batch number, quantity) with the supplier’s packing list or invoice. Ensure that the stated double-check or special packaging instructions are recognized in the supplier’s documentation.
    2. Any major discrepancy (e.g., 20 bags arrived instead of 25, or the batch number doesn’t match the PO) must be documented in the Raw Material Receiving Register and immediately reported to QA and Procurement.

5.3 Inspecting Double-Checked Packaging

Double-checked materials often feature additional seals or markings indicating that the supplier performed a final quality check. Verifying these markers and the condition of both bag layers is essential.

  1. Outer Bag Inspection

    1. Examine the outer bag’s surface for cuts, punctures, moisture damage, or evidence of tampering. If the outer bag is transparent, check that the inner bag remains intact.
    2. Locate any specialized “Double-Checked” or “QC Passed” seals. Ensure they are unbroken and properly affixed. If the seal is broken or missing, tag the material as “Suspect” for QA intervention.
  2. Inner Bag Verification

    1. If feasible without compromising sterility or contamination control, gently separate the outer bag to confirm the inner bag is fully sealed. If the material is known to be sensitive or sterile, consult QA before opening the outer bag.
    2. Check the labeling on the inner bag to confirm that it matches the outer bag label (material name, batch number, net weight, etc.). Report any mismatch to QA. Minor label variations might be acceptable but require QA approval.
  3. Label Accuracy and Completeness

    1. The label on each bag should include:
      • Material name
      • Batch/lot number
      • Net weight or quantity
      • Expiry or retest date (if applicable)
      • Any special handling instructions (e.g., “Store in cool, dry place”)
    2. If the label lacks vital information or the text is unreadable, isolate those bags under “Label Discrepancy” status and seek QA guidance on re-labeling or rejection.
See also  SOP for Checking Raw Material Shipment against Approved Purchase Order (PO) - V 2.0

5.4 Verifying Double-Check Documentation

Suppliers may provide additional paperwork (e.g., a certificate verifying that two independent checks were done before sealing). Confirming this documentation ensures compliance with any contractual or regulatory requirements for extra packaging safeguards.

  1. Supplier’s Quality Certificate

    1. Check if a separate certificate or statement accompanies the shipment stating “Double-Checked” or “Checked by two inspectors,” referencing the batch number. Compare the batch details with those on the bag labels.
    2. Any missing or inconsistent certificate should be flagged for QA decision. Procurement may contact the supplier if these documents were contractually required but not supplied.
  2. QA Confirmation

    1. After verifying that the double-check documentation aligns with the actual packaging seals and batch info, QA can determine if additional sampling or quarantine is needed.
    2. If documentation is incomplete or contradictory, QA might require advanced testing (ID test, microbial check) or hold the material until proper verification is obtained.

5.5 Documentation and Recording Discrepancies

Accurate record-keeping is essential for traceability and for triggering corrective actions if needed.

  1. Raw Material Receiving Register Updates

    1. Enter the date of receipt, supplier name, material name, batch number, quantity received, and PO reference in Annexure-1. Note under “Remarks” if the packaging meets double-check requirements, or if any anomalies (e.g., broken seals) were observed.
    2. Ensure each entry is signed or initialed by the Warehouse Personnel performing the inspection. If an electronic Warehouse Management System (WMS) is used, log the event with appropriate user credentials and timestamps.
  2. Quarantine or Rejection Labels

    1. If suspicious or damaged double-bagged materials are found, label them as “Hold—Damaged Packaging” or “Hold—Incorrect Label,” placing them in quarantine. Record their location in the inventory system for easy retrieval by QA.
    2. Warehouse Personnel must avoid mixing quarantined bags with standard stock to prevent accidental usage or cross-contamination.
  3. Deviation or Non-Conformance Reports

    1. If a significant mismatch occurs (wrong batch, major damage, missing double-check documentation), QA or the Warehouse Manager raises a deviation. Attach photos, shipping documents, and relevant notes to support the report.
    2. Procurement may contact the supplier to address recurring discrepancies in double-bagged shipments, potentially reviewing their compliance with the double-check agreement.

5.6 QA Evaluation and Next Steps

QA reviews the inspection records, verifying packaging integrity and label consistency before materials are released or subjected to further testing.

  1. QA Decision

    1. If the double-checked packaging is intact and aligns with the PO and supplier documents, QA authorizes the material for standard QC release testing or direct storage in the quarantine area, pending full release.
    2. In cases of suspected contamination, severe packaging defects, or labeling errors, QA may direct the Warehouse to keep the affected materials under quarantine or reject them outright if they do not meet GMP standards.
  2. Sampling (If Required)

    1. When QA or internal procedures mandate sampling, QC collects samples according to the Sampling Log (Annexure-2) and relevant SOPs. This is crucial if the double-check or double-bagging shows signs of tampering or partial damage.
    2. Record any test results (e.g., ID test, impurity profile) and alert QA to finalize acceptance or rejection based on analytical findings.
  3. Final Release or Rejection

    1. Following QC testing (if performed) and a satisfactory review by QA, the materials can be approved for production use or further storage. Update the inventory status in the WMS or receiving log, marking them “Approved.”
    2. If QA concludes the materials are unusable or do not meet the agreed double-check standards, they issue a rejection. Warehouse Personnel label such bags “Rejected” and store them in a segregated area, awaiting return-to-vendor or disposal according to GMP requirements.
See also  SOP for Verification of Supplier Documents for Raw Materials - V 2.0

5.7 Follow-Up and CAPA

Ensuring ongoing compliance and quality improvement may involve investigating recurring supplier issues or enhancing internal processes for double-bagged materials.

  1. Review Supplier Performance

    1. If repeated incidents of broken seals, incorrect labeling, or missing double-check documents occur, Procurement and QA may consider performing supplier audits or reevaluating the supplier’s approval status on the AVL.
    2. Highlight any improvements or corrections required in future purchase agreements or through formal CAPA if the supplier’s error is systemic.
  2. Internal Process Enhancements

    1. Analyze deviations or non-conformance reports to spot trends (e.g., frequent outer bag tears). Adjust this SOP or training programs if the inspection process can be improved, such as using specialized support stands or adjusting how forklift tines are positioned.
    2. Record any procedural changes and confirm that the updated practices are clearly communicated to Warehouse and QA personnel through refresher training.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • PO: Purchase Order
  • CoA: Certificate of Analysis
  • AVL: Approved Vendor List
  • CAPA: Corrective and Preventive Action
  • WMS: Warehouse Management System

7. Documents

  1. Raw Material Receiving Register (Annexure-1)
  2. Sampling Log (Annexure-2), if sampling is performed
  3. Purchase Orders (PO), Invoices, Packing Lists
  4. Supplier Double-Check Certificates, CoAs, or Additional QC Documents
  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 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
  • Company-Specific Procurement and Warehouse Policies
  • Approved Vendor List (AVL) Documentation

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 Double-Check Seal Remarks
01/02/2025 ABC Specialty Supplies API-X X-2025-DB1 PO-77777 Intact No Visible Damage
02/02/2025 XYZ Pharma Distributors Excipient-Y Y-2025-DB5 PO-88888 Broken Seal Outer Bag Torn

Annexure-2: Sampling Log

Date Material Name Batch Number Sampling Personnel QC Test Performed Result Remarks
01/02/2025 API-X X-2025-DB1 John Doe Identification, Purity Pass Double Bag Check Confirmed
02/02/2025 Excipient-Y Y-2025-DB5 Jane Smith Basic ID Test Pending Broken Seal, QA Hold

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 procedures for double-checked, double-bagged materials
01/02/2025 2.0 Expanded Guidance Standardization of Document QA Head All All Included more detailed inspection steps and extra documentation for supplier’s double-check certificates
Raw Material Warehouse V 2.0 Tags:, , , , , , , , , , , , , , , , , , , , , , , ,