SOP for Physical and Visual Inspection of Incoming Raw Materials – V 2.0

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SOP for Physical and Visual Inspection of Incoming Raw Materials – V 2.0

Standard Operating Procedure for Physical and Visual Inspection of Incoming Raw Materials

Department Warehouse / Quality Assurance / Quality Control
SOP No. SOP/RM/016/2025
Supersedes SOP/RM/016/2022
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) describes the process for conducting a detailed physical and visual inspection of all incoming raw materials. Physical and visual inspections are essential components of the receiving process, ensuring that materials are free from obvious damage, contamination, or labeling discrepancies before they enter the organization’s storage or manufacturing areas. By adhering to this SOP, the company ensures Good Manufacturing Practice (GMP) compliance, reduces the risk of using compromised or adulterated materials, and maintains a safe, efficient production environment. Regular and meticulous inspections uphold product quality, regulatory compliance, and internal standards by detecting early any anomalies that could affect final product integrity.

2. Scope

This SOP applies to all raw materials—active pharmaceutical ingredients (APIs), excipients, intermediates, chemicals, and any other items—delivered to the facility’s receiving dock or warehouse. The procedure covers:

  • Assessment of the condition of packaging, seals, and labels upon arrival.
  • Verification of product name, batch/lot numbers, and any specific storage or handling instructions noted on the labels.
  • Identification of physical defects such as dents, tears, or water damage that might compromise material integrity.
  • Documentation of inspection findings and subsequent actions, such as quarantine, further testing, or acceptance.

All Warehouse Personnel, Quality Assurance (QA), and Quality Control (QC) staff involved in receiving, inspecting, and approving raw materials must follow this SOP. Procurement may also refer to these guidelines when engaging with suppliers to ensure that packaging specifications and labeling requirements meet the company’s and regulatory standards.

3. Responsibilities

  • Warehouse Personnel:

    • Conduct the initial visual inspection upon unloading materials and document any findings in the Raw Material Receiving Register (Annexure-1).
    • Report obvious signs of damage, contamination, or non-compliance (e.g., missing labels) to QA for guidance on quarantine or rejection.
    • Ensure that inspected materials are correctly labeled and placed either in the designated quarantine or approved storage area, according to QA instructions.
  • Quality Assurance (QA) Team:

    • Establish and maintain inspection criteria, including pass/fail conditions for packaging and labeling integrity.
    • Review and approve any decisions regarding quarantine or rejection of materials based on physical inspection results.
    • Initiate and oversee any deviations or non-conformance reports related to physical/visual inspection findings.
    • Approve any corrective actions taken to rectify labeling or packaging issues identified during inspection.
  • Quality Control (QC) Team:

    • Conduct sampling or additional tests if the physical inspection suggests potential contamination or mismatch (e.g., if the container labeling does not match the PO or if abnormal odors are detected).
    • Collaborate with QA to determine if a suspected defect requires further analytical testing or an in-depth investigation.
  • Procurement Department (If Applicable):

    • Ensure that Purchase Orders (POs) specify clear packaging and labeling requirements for suppliers.
    • Coordinate with suppliers if repeated packaging or labeling issues are identified, working with QA to implement corrective measures.

4. Accountability

The Warehouse Manager is accountable for ensuring that physical and visual inspections are executed consistently and that all findings are documented. The QA Manager holds the final authority on any decision regarding acceptance or rejection of materials, especially if the inspection reveals significant defects. Any changes to this SOP must be approved by QA Management to remain consistent with GMP guidelines and regulatory requirements. Procurement may be contacted if supplier or PO-related issues arise, while QC supports QA in determining if deeper testing is warranted.

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5. Procedure

5.1 Preparation and Area Setup

Proper readiness ensures that personnel can inspect incoming materials effectively and safely, reducing the likelihood of overlooking defects or causing additional damage.

  1. Receiving Dock Readiness

    1. Clean and organize the receiving area prior to the arrival of shipments. Remove any unrelated materials, debris, or spills that could interfere with inspection activities.
    2. Verify that appropriate material-handling equipment (forklifts, pallet jacks) is operational. Ensure that these vehicles have been maintained to avoid oil leaks or mechanical failures that could damage packaging.
    3. Have any necessary tools on hand—such as flashlights for detailed inspection, PPE (gloves, safety shoes, etc.)—to mitigate risks during unloading and handling.
  2. Documentation and Forms

    1. Obtain copies of the PO, packing list, and any shipping or regulatory documentation (e.g., CoA, SDS) to cross-check labels and container counts.
    2. Keep the Raw Material Receiving Register (Annexure-1) accessible, whether in paper or electronic form, for immediate documentation of findings.
    3. If using an electronic Warehouse Management System (WMS), ensure user login credentials are valid and the system is ready to record inspection results.
  3. Personnel Briefing

    1. Conduct a quick briefing with Warehouse Personnel and QA/QC staff (if present) about the expected shipment details, such as material types, quantities, and any special instructions (e.g., fragile packaging, cold chain requirements).
    2. Reiterate the safety and inspection protocols: how to handle suspected contamination, labeling mismatches, or damaged containers. Emphasize immediate quarantine for items that appear compromised.

5.2 Unloading and Preliminary Checks

During unloading, Warehouse Personnel observe and record any obvious damage, contamination, or labeling problems. These initial checks greatly reduce the chances of storing defective materials.

  1. Vehicle Inspection

    1. Compare the cargo seal number (if provided) on the delivery vehicle with shipping documents. If any discrepancy or broken seal is noted, escalate to QA. Document details in the Raw Material Receiving Register.
    2. Check the general cleanliness and condition of the vehicle’s cargo area. If the environment seems potentially unsanitary, note it as a remark. This may prompt QA or QC to request additional checks.
  2. Basic Container Condition

    1. Examine the outer packaging (pallets, boxes, drums) for tears, dents, or punctures. Look for signs of moisture damage, such as watermarks or mold. If found, set aside those items for QA review.
    2. Observe any unusual odors or stains. Mark these containers as “Suspect” and inform QA to decide if immediate quarantine is required.
  3. Quantity Confirmation

    1. Count the number of containers received and compare with the packing list or PO. Note any shortages or overages in the receiving log. Even if containers appear physically fine, discrepancies in quantity must be reported.
    2. For partial shipments or split deliveries, ensure that the quantity aligns with the supplier’s documentation. Label partial shipments clearly to avoid confusion during later inventory management processes.

5.3 Detailed Physical and Visual Inspection

Once the materials are unloaded and lined up in the inspection area, Warehouse Personnel or QA staff examine containers more thoroughly for packaging integrity and label accuracy.

  1. Packaging Integrity

    1. Check that seals or shrink-wrap around pallets or boxes remain intact. For drums or carboys, ensure that lids or caps are tightly sealed with no evidence of leakage.
    2. Inspect metal or plastic bands, if any, ensuring none are snapped or missing. If the material is in bags, look for small tears or holes that could allow product spillage or contamination.
  2. Label Verification

    1. Confirm each container’s label includes at least the material name, batch/lot number, and any relevant storage or handling instructions (e.g., “Keep Dry,” “Store at 2–8°C”). If the label format deviates significantly from the company’s requirements, consult QA.
    2. Cross-check the label details against the PO, packing list, and any CoA if available. Mismatched batch numbers or missing information (e.g., expiry date, manufacturer’s name) must be flagged for QA to decide if quarantining or rejecting the batch is necessary.
    3. Examine label legibility. Faded or smeared text can lead to misidentification. Document any labeling deficiencies in the receiving log.
  3. Physical State of the Material

    1. When feasible, gently shake or tilt containers (especially for liquids or powders) to check for unusual consistency (e.g., caking of powdered materials, clumping, or layering for liquids). If the container is sealed, do not open it at this stage; only proceed if QA instructs sampling or deeper inspection.
    2. If the container is see-through (e.g., transparent plastic carboys), visually inspect the material for floating particles or unexpected discolorations. Any anomaly could suggest contamination or product degradation.
  4. Record Observations

    1. Fill out the relevant fields in the Raw Material Receiving Register, noting container numbers, the condition of packaging, label status, and any remarks on unusual findings.
    2. Attach photos (if standard operating procedure permits) to provide QA or QC with more immediate evidence of damage or anomalies. Store these images with the batch record if the system allows attachments.
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5.4 Handling Discrepancies or Damaged Materials

Prompt and consistent action on any identified issues prevents unauthorized or unsafe materials from entering production or mingling with approved stock.

  1. Minor Packaging Damage

    1. If only external packaging is slightly damaged (e.g., torn shrink-wrap) but the primary container (bag, drum, or sealed pouch) remains intact, Warehouse Personnel can note the damage, re-wrap if necessary, and proceed. However, this must be recorded, and QA notified for final approval.
    2. QA may allow usage of such materials if the contents are verified safe, instructing a more thorough inspection or sampling if necessary.
  2. Significant Damage or Potential Contamination

    1. If containers show major issues (e.g., large holes, product spillage, wet or moldy surfaces), segregate them in the quarantine zone. Label them as “Damaged – Awaiting QA Decision.”
    2. Procurement or QA may then contact the supplier for credit, replacement, or an investigation if repeated shipping damage occurs.
  3. Label Discrepancies or Missing Information

    1. If the label lacks essential data (batch number, material name, expiry date), place the container under quarantine. QA must decide if re-labeling or further verification is permissible. Materials with missing or suspicious labels pose a risk of misidentification.
    2. In certain cases, QA may authorize a label correction if the supplier provides official written confirmation. This must be clearly documented in the batch record or receiving log.
  4. Immediate Notifications

    1. For severe contamination, suspected tampering, or potential safety hazards, promptly inform QA and QC. They may instruct a hold or rejection procedure to protect staff and final products.
    2. Major discrepancies often necessitate a deviation report, referencing the batch number, description of the issue, and recommended actions (return to vendor, rework, or disposal).

5.5 Quarantine and Documentation

Suspect materials or those with questionable physical integrity remain in the quarantine area until QA makes a final decision based on further inspection or additional testing.

  1. Quarantine Labeling

    1. Affix a “Quarantine” label to each container that does not meet immediate acceptance criteria or requires further inspection. Mark the date of receipt, batch number, and reason for hold (e.g., “Damaged packaging,” “Label mismatch”).
    2. Record the quarantine location (rack, shelf, or cage) in the Warehouse Management System or manual logs. Restrict access to ensure no inadvertent usage occurs.
  2. Coordination with QA/QC

    1. QA reviews the inspection findings and determines if a more detailed evaluation (chemical or microbial tests) is necessary. QC may collect samples if the physical damage suggests contamination risk.
    2. If QA concludes the damage is critical or the labeling is irreconcilably incorrect, they may reject the material. Procurement handles returns or disposal arrangements, depending on supplier agreements and regulatory guidelines.
  3. Receiving Register Updates

    1. Warehouse Personnel must finalize the Raw Material Receiving Register (Annexure-1) with the inspection date, any remarks on container status, quarantine details, and references to QA’s instructions (e.g., “Awaiting full test results,” “Rejected,” “Approved pending final sampling”).
    2. Signature or initials of both Warehouse and QA staff on the relevant entries help maintain accountability and a robust audit trail.
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5.6 Final Acceptance or Rejection

Once QA reviews the inspection findings (and any additional tests if required), they determine whether to accept, reject, or place materials on hold for further actions.

  1. QA Approval

    1. If the materials pass physical and visual inspections and meet the labeling requirements, QA may authorize them for further QC testing or direct placement in quarantine for standard release procedures.
    2. After completing all standard release tests and procedures (as mandated by the full QC process), QA can grant final approval for use in manufacturing or other in-house processes.
  2. Rejection Criteria

    1. If physical/visual defects are critical (e.g., severe contamination, structural damage exposing raw materials, significant labeling failures), QA rejects the lot. Label containers “Rejected” and store them in a segregated area to prevent accidental use.
    2. Procurement may coordinate with the supplier on returns, refunds, or credit if the cause of rejection is supplier-related. Retain all documentation for potential audit or claims procedures.
  3. Deviations and CAPA

    1. Major or recurring issues in the physical/visual inspection process trigger a formal deviation or non-conformance record, referencing the batch number, findings, and recommended solutions. QA drives the CAPA process to prevent recurrence.
    2. Suppliers who consistently deliver substandard packaging or mislabeled materials may require re-evaluation on the Approved Vendor List (AVL), with Procurement and QA working collaboratively to ensure future compliance.

6. Abbreviations

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

7. Documents

  1. Raw Material Receiving Register (Annexure-1)
  2. Sampling Log (Annexure-2) (If sampling or further testing is required)
  3. Purchase Orders, Invoices, and Packing Lists
  4. Certificates of Analysis (CoAs)
  5. Deviation or Non-Conformance Reports (if applicable)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice 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 Warehouse, QA, and Procurement 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 Condition Remarks
01/02/2025 ABC Chemicals API X X-2025-01 PO-10001 Good No Visible Damage
02/02/2025 XYZ Supplies Excipient Y Y-2025-02 PO-10002 Damaged Outer Box Set Aside for QA Review

Annexure-2: Sampling Log

Date Material Name Batch Number Sampling Personnel QC Test Performed Result Remarks
01/02/2025 API X X-2025-01 John Doe Basic ID Test Pass N/A
02/02/2025 Excipient Y Y-2025-02 Jane Smith Visual, pH Pending Damaged Packaging Sample

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 procedure for physical and visual inspection
01/02/2025 2.0 Enhanced Inspection Criteria Standardization of Document QA Head All All Added detailed steps for labeling verification and quarantine decisions
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