SOP for Inspection of Incoming Raw Materials Packaging – V 2.0

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SOP for Inspection of Incoming Raw Materials Packaging – V 2.0

Standard Operating Procedure for Inspection of Incoming Raw Materials Packaging

Department Quality Assurance / Warehouse
SOP No. SOP/RM/003/2025
Supersedes SOP/RM/003/2022
Page No. Page 1 of 12
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a detailed, GMP-compliant process for inspecting the packaging of incoming raw materials. Proper packaging integrity is critical to ensuring that materials remain unadulterated, free from contamination, and stable during storage and transportation. This SOP outlines the criteria, methods, and responsibilities for thoroughly examining packaging upon receipt to identify any damage, tampering, or non-conforming conditions that might affect material quality or safety. By adhering to this procedure, the organization ensures that only materials with intact and compliant packaging progress to sampling and subsequent use, thereby minimizing the risk of compromised product quality.

2. Scope

This SOP applies to all incoming raw materials—pharmaceutical ingredients, excipients, chemicals, and other materials—received at the company’s warehouse or designated receiving area. It covers the inspection of primary, secondary, and tertiary packaging layers to detect and document any deviations from established packaging standards. The procedure includes the roles of warehouse personnel, Quality Assurance (QA), Quality Control (QC), and other involved departments. It also addresses the handling of materials found with damaged or improper packaging, including quarantine, disposal, or rework instructions where applicable.

3. Responsibilities

  • Warehouse Personnel:
    • Receive incoming shipments and conduct an initial visual assessment of packaging.
    • Report any observed damage or non-conformance to QA immediately.
    • Quarantine any suspicious or compromised packaging until QA or QC can perform further evaluation.
    • Ensure that the Raw Material Receiving Register is accurately filled out with details on packaging integrity.
  • Quality Control (QC) Team:
    • Provide guidelines or checklists for packaging integrity checks as needed.
    • Perform further inspection if requested by QA, particularly for materials that are critical or high-risk.
    • Assist in determining whether compromised packaging necessitates special sampling methods or additional testing.
  • Quality Assurance (QA) Team:
    • Define packaging specifications and acceptable criteria in collaboration with Procurement and Regulatory teams.
    • Review and approve or reject materials based on inspection findings.
    • Maintain records of packaging deviations and approve any corrective actions or rework instructions.
    • Ensure that any non-conforming packaging issue is escalated or investigated according to regulatory requirements and internal policies.
  • Procurement Department:
    • Specify packaging requirements in Purchase Orders (POs) and ensure that suppliers understand these criteria.
    • Coordinate with suppliers to rectify repeated packaging problems or to confirm packaging specifications.
    • Update the Approved Vendor List (AVL) based on packaging compliance and vendor performance.
  • Safety and Compliance Officers (If Applicable):
    • Oversee the handling and storage of materials with special packaging requirements (e.g., hazardous substances, temperature-sensitive items).
    • Provide updates on regulatory changes that may affect packaging standards or labeling requirements.

4. Accountability

Overall accountability for this SOP resides with the Head of Quality Assurance (QA), who must ensure the procedure is effectively implemented and continuously updated to meet regulatory standards. The Warehouse Manager is responsible for day-to-day compliance within the receiving area, while the QA Manager or Head authorizes any revisions to the SOP and oversees investigations into major packaging non-conformances.

See also  SOP for Unloading and Moving Raw Materials to the Quarantine Area - V 2.0

5. Procedure

5.1 Receiving Raw Materials

Although this procedure focuses on packaging inspection, proper receipt of the materials sets the foundation for a thorough evaluation.

  1. Initial Receipt

    1. Upon the arrival of a delivery vehicle, Warehouse Personnel confirm the PO number, supplier details, and the quantity of incoming materials.
    2. All relevant documentation (e.g., delivery note, packing list) must accompany the shipment. If documents are missing, notify QA and Procurement immediately.
    3. Note any visible issues—such as crushed boxes or leaking containers—on the delivery note and inform QA for further instructions.
  2. Unloading and Segregation

    1. Unload materials carefully using appropriate equipment (e.g., forklifts, pallet jacks) to prevent further damage.
    2. Place the materials in a designated receiving area, keeping them separate from approved inventory and quarantine zones.
    3. Record basic information (date, time, supplier, PO number) in the Raw Material Receiving Register (Annexure-1) for traceability.
  3. Preparatory Check

    1. Ensure you have the relevant packaging specifications or acceptance criteria readily available before conducting a detailed inspection. These criteria might include guidelines on container type, seal integrity, label format, and hazard symbols if applicable.
    2. Confirm that the receiving area is well-lit and clean, reducing the risk of missing small punctures or tears during inspection.

5.2 Visual Inspection and Documentation Verification

A thorough visual inspection is vital to ensure that raw materials arrive in compliant packaging that protects the integrity of the product. This step also involves verifying that the supplied documents correctly describe the packaging and match the physical condition of the materials.

  1. External Packaging Inspection

    1. Examine the outermost packaging (boxes, shrink wrap, drums, or pallets) for signs of damage, such as tears, dents, watermarks, or evidence of tampering (e.g., broken seals).
    2. Confirm that any handling or hazard labels are clearly visible and correspond to the type of material (e.g., flammable, corrosive, or temperature-sensitive markings).
    3. Check for correct orientation labels (e.g., “This Side Up”) to ensure the shipment was handled appropriately during transit.
  2. Internal Packaging and Container Inspection

    1. If the outer packaging is intact, proceed to carefully open a sample of boxes or pallets to inspect the secondary or primary packaging layers (e.g., sealed pouches, jars, or drums).
    2. Look for leaks, broken seals, or compromised container closures. Ensure that the seals have not been tampered with or replaced.
    3. Review batch number, expiry date, and labeling details on individual containers to ensure consistency with the documentation (Certificate of Analysis (CoA), packing list, or labels described in the Purchase Order).
  3. Documentation Alignment

    1. Compare the packaging information in the supplier documentation with the actual materials (e.g., container type and size mentioned in the CoA or specification sheet). Any mismatch must be reported to QA for further investigation.
    2. If documentation indicates a specific packaging standard (e.g., UN-certified packaging for hazardous goods), verify that the containers bear the required certification markings.
  4. Recording Observations

    1. Document any irregularities, including minor dents, partially missing labels, or faint print, in the Raw Material Receiving Register. Take photos if the discrepancy is significant.
    2. If the packaging is severely compromised—exposing the raw material or risking contamination—label it as “Damaged” and move the item to a segregated area for QA evaluation.

5.3 Sampling and Quality Control

Sampling and QC testing verify whether the material inside the packaging is still compliant with quality standards after transit. Packaging that appears compromised may require special sampling procedures or additional scrutiny.

See also  SOP for Handling and Movement of Quarantined Hazardous Raw Materials - V 2.0

  1. Sampling Authorization

    1. QA or QC authorizes sampling only if packaging integrity is deemed acceptable. If packaging is not acceptable, QA determines if re-sampling under controlled conditions or special containment is warranted.
    2. Document the packaging status on the sampling request form or in relevant QC logs.
  2. Sample Collection

    1. QC personnel don appropriate PPE (e.g., gloves, lab coats, masks) before opening sealed containers, especially for high-risk or sensitive materials.
    2. Follow the established sampling plan regarding sample size and sampling points. If packaging damage is localized (e.g., a small puncture in one bag), gather additional samples from that compromised area for thorough analysis.
    3. Label samples with the material name, batch number, sampling date, and note any packaging observations (e.g., “Torn seal on one container”). Record this in the Sampling Log (Annexure-2).
  3. QC Testing and Correlation

    1. Perform physical, chemical, or microbial tests per approved methods. Compare results to internal specifications and the supplier’s CoA if provided.
    2. If any test results raise concerns—particularly if packaging was compromised—initiate an OOS investigation or follow the deviation process to determine whether the material is still safe to use.

5.4 Quarantine and Labeling

Any raw materials with questionable packaging integrity must be quarantined to prevent unauthorized use or accidental mixing with conforming stock. This section outlines the quarantine and labeling protocol.

  1. Quarantine Initiation

    1. Mark suspect materials with a “Hold” or “Quarantine” label. Indicate the reason (e.g., “Packaging Damage”) and the date of quarantine.
    2. Store quarantined materials in a segregated area with controlled access. Maintain separation from approved materials to prevent cross-contamination.
  2. Labeling Requirements

    1. Include clear instructions on each quarantined container or pallet, specifying “Do Not Use” until QA completes its assessment.
    2. Ensure that all labeling is legible and robust enough to remain in place until final disposition (release, rework, or rejection) is decided.
  3. Disposition Decision

    1. QA reviews the quarantine documentation and any relevant test results or investigations (e.g., if additional testing was performed on the compromised packaging). QA then makes the final decision to release, rework, or reject the material.
    2. Keep a record of the final decision in both the Raw Material Receiving Register and an internal Deviation or Non-Conformance Report as appropriate.

5.5 Approval and Release

If packaging meets the acceptance criteria and QC results confirm that the raw material is within specification, QA provides final approval to release the materials for further processing or manufacturing use.

  1. QA Review

    1. QA reviews the packaging inspection records, verifying that all noted observations are either acceptable or resolved.
    2. If no critical packaging issues are identified and test results are satisfactory, QA authorizes Warehouse Personnel to remove quarantine labels (if applied) and relabel the material as “Approved.”
  2. Release Labeling and Documentation

    1. Affix a “Released” or “Approved” label to each container, including the release date and the signature or initials of the QA approver.
    2. Update the inventory management system to reflect the new status of the materials. Include any notes regarding special handling instructions or observed packaging anomalies that do not affect material integrity.
  3. Rejected Materials

    1. If QA determines the packaging defect renders the material unsafe or non-compliant, mark it as “Rejected.” Move the material to a separate rejection area pending return to supplier, disposal, or other agreed disposition.
    2. Procurement may communicate with the supplier regarding any consistent or critical packaging issues for a future corrective action plan.
See also  SOP for Verification of Certificate of Analysis (CoA) During Material Receipt - V 2.0

5.6 Documentation and Record-Keeping

Comprehensive documentation is essential for regulatory compliance and for maintaining a robust audit trail. All packaging inspection findings, whether minor or major, should be recorded accurately.

  1. Raw Material Receiving Register

    1. Enter key details of the packaging inspection—date, supplier, PO number, material name, batch number, and any remarks—into the Raw Material Receiving Register (Annexure-1).
    2. Ensure the person responsible for the inspection signs or initials the entry to confirm accountability.
  2. Sampling Log

    1. QC personnel must update the Sampling Log (Annexure-2) with any special notes regarding packaging conditions at the time of sampling.
    2. Attach relevant test results or cross-reference them in the log if an electronic system is used.
  3. Deviation or Non-Conformance Reports

    1. Major packaging issues that could affect material integrity, safety, or regulatory compliance require a formal Deviation or Non-Conformance Report. Include photos, descriptions, root cause analysis (if identified), and proposed corrective actions.
    2. QA must review and approve the final disposition, whether rework, return to supplier, or disposal.
  4. Archiving and Retention

    1. Retain all packaging inspection records, Deviation Reports, and supporting documentation for the duration required by local regulations or company policy (commonly five years or more).
    2. Ensure that only authorized personnel can modify or retrieve these records, maintaining data integrity and traceability.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • PO: Purchase Order
  • CoA: Certificate of Analysis
  • PPE: Personal Protective Equipment
  • AVL: Approved Vendor List
  • OOS: Out of Specification

7. Documents

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

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 Packaging and Labeling Standards

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 Packaging Condition PO Number Remarks
01/02/2025 XYZ Pharma Supplies Active Ingredient A Lot 2025-01 Intact PO-12345 No Visible Damage
02/02/2025 ABC Chemicals Excipient B Lot 2025-02 Dented Drum PO-67890 Segregated for QA Check

Annexure-2: Sampling Log

Date Material Name Batch Number Sampling Personnel QC Test Performed Result
01/02/2025 Active Ingredient A Lot 2025-01 Jane Doe Assay, Purity Pass
03/02/2025 Excipient B Lot 2025-02 John Smith Microbial Limits Pass

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 inspection protocol for incoming packaging
01/02/2025 2.0 Expanded Procedures Standardization and Detailing of Packaging Checks QA Head All All Included additional steps for internal and external packaging inspection
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