SOP for Receiving Hazardous Chemicals and High-Risk Raw Materials – V 2.0

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SOP for Receiving Hazardous Chemicals and High-Risk Raw Materials – V 2.0

Standard Operating Procedure for Receiving Hazardous Chemicals and High-Risk Raw Materials

Department Quality Assurance / EHS (Environment, Health & Safety)
SOP No. SOP/RM/006/2025
Supersedes SOP/RM/006/2022
Page No. Page 1 of 14
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 define a safe, GMP-compliant process for receiving hazardous chemicals and high-risk raw materials. Such materials often pose significant health, safety, environmental, or regulatory risks and require specialized handling and storage conditions. By following the steps detailed in this SOP, the organization ensures the safety of personnel, protection of product quality and integrity, and adherence to local and international regulations. Proper management of these materials at the point of receipt is critical for preventing accidental exposure, contamination incidents, or regulatory non-compliance.

2. Scope

This SOP applies to all incoming hazardous chemicals and high-risk raw materials received at our facility’s loading docks or designated receiving areas. It includes chemicals classified as flammable, corrosive, toxic, reactive, or otherwise hazardous; controlled substances with strict regulatory oversight; and any other materials identified by the organization’s risk assessment procedures as high risk. This document covers tasks carried out by Warehouse Personnel, Quality Control (QC), Quality Assurance (QA), and Environment, Health & Safety (EHS) teams. It encompasses inspection, verification of required documentation, quarantine and labeling, and final release or rejection decisions based on safety and quality criteria.

3. Responsibilities

  • Warehouse Personnel:

    • Receive shipments of hazardous/high-risk materials and perform an initial inspection of packaging and labeling.
    • Handle hazardous materials using appropriate material handling equipment and personal protective equipment (PPE).
    • Quarantine incoming materials until QA/EHS confirms proper labeling, documentation, and compliance with specifications.
    • Record receipt data in the Raw Material Receiving Register, ensuring all notes on hazards or observed anomalies are accurately documented.
  • Quality Control (QC) Team:

    • Conduct sampling and testing as per the approved plan, especially if materials have stringent purity, potency, or other critical parameters.
    • Review Certificates of Analysis (CoA) or safety data to confirm materials meet specified acceptance criteria.
    • Coordinate with QA and EHS to evaluate the potential impact of any deviations or non-conformances identified during testing.
  • Quality Assurance (QA) Team:

    • Ensure that hazardous or high-risk materials comply with company standards, regulatory requirements, and GMP guidelines.
    • Review and approve all documentation (e.g., CoA, Safety Data Sheets) and oversee any required deviations or CAPA (Corrective and Preventive Action) processes.
    • Authorize the final release or rejection of materials based on QC test results, safety assessments, and supplier conformity.
    • Maintain records of any deviations, rejections, and investigations in accordance with regulatory record-keeping requirements.
  • Environment, Health & Safety (EHS) Team:

    • Provide guidelines for safe handling, storage, and transportation of hazardous or high-risk materials.
    • Train personnel on the correct use of PPE, spill containment procedures, and emergency response measures.
    • Ensure compliance with local and international safety regulations (e.g., OSHA, REACH, or other jurisdiction-specific requirements).
    • Collaborate with QA during risk assessment to classify materials as high-risk and recommend necessary controls.
  • Procurement Department:

    • Source materials only from approved vendors listed on the company’s Approved Vendor List (AVL), ensuring they meet safety and quality standards.
    • Obtain all necessary shipping and safety documentation (including Safety Data Sheets (SDS) and permits) from suppliers.
    • Coordinate with suppliers if discrepancies or missing data are identified, facilitating timely resolution.
    • Ensure that any special shipping or packaging requirements (e.g., temperature-controlled transport, hazard labels) are clearly communicated to vendors.
See also  SOP for Verifying Vendor Compliance Before Accepting Raw Materials - V 2.0

4. Accountability

The Head of Quality Assurance (QA) and the EHS Manager jointly hold accountability for the consistent application of this SOP. The QA Manager oversees GMP compliance, while the EHS Manager ensures adherence to safety regulations. Any deviations from these procedures must be documented, investigated, and approved by QA and EHS as appropriate. Warehouse Management is accountable for day-to-day compliance with safe handling and documentation practices, while Procurement guarantees that all necessary shipping and regulatory paperwork is in order before materials arrive on-site.

5. Procedure

5.1 Pre-Receipt Preparations

  1. Documentation Readiness

    1. Procurement must provide all available documentation (Purchase Order (PO), Safety Data Sheet (SDS), Certificate of Analysis (CoA), etc.) to Warehouse and EHS personnel before the shipment arrives.
    2. EHS reviews the SDS to identify the hazard class (flammable, corrosive, toxic, etc.) and any special storage/handling conditions (e.g., temperature, segregation requirements).
  2. Safety Precautions

    1. Ensure that suitable PPE (e.g., chemical-resistant gloves, goggles, face shields, respirators) is available for handling the specific class of hazardous material.
    2. Verify that designated spill kits, fire extinguishers, and first-aid equipment are accessible in the receiving area.
    3. Prepare the quarantine area for the hazardous or high-risk material, ensuring secondary containment measures (e.g., spill trays, bunded pallets) are in place if required.
  3. Receiving Area Checks

    1. Confirm that the receiving dock is clean and free of unrelated materials that could become contaminated or react if a spill occurs.
    2. Review the facility’s emergency response procedures with staff to ensure readiness for potential leaks or accidents during offloading.

5.2 Initial Inspection and Offloading

  1. Vehicle Inspection

    1. Check the delivery vehicle for any signs of leakage, damage, or improper labeling. If the vehicle shows evidence of spills or chemical contamination, do not proceed with unloading until QA/EHS is notified.
    2. Confirm the quantity of containers (drums, IBCs, bags) against the shipping documents and PO. Note any discrepancies.
  2. Label and Placard Verification

    1. Ensure that all hazard labels (e.g., NFPA or GHS symbols) are present, legible, and correctly affixed to each container as per regulatory requirements.
    2. Review transport placards on the vehicle (e.g., UN numbers for hazardous chemicals) to verify they match the materials being delivered.
  3. Safe Unloading

    1. Use appropriate material handling equipment (forklifts, pallet jacks) designed or adapted for hazardous materials. Avoid creating sparks if flammable chemicals are involved.
    2. Personnel must wear the designated PPE. If the material is extremely hazardous, additional protective measures (e.g., full-body suits, respirators) may be necessary per the SDS and EHS guidance.
    3. Segregate any visibly damaged or leaking containers immediately in a designated holding area, and inform EHS/QA for further evaluation.

5.3 Documentation Verification and Quarantine

  1. Document Review

    1. Match the supplier’s packing list, CoA, SDS, and any regulatory permits (if applicable) against the PO and internal specifications.
    2. Check the batch or lot numbers, ensuring they correspond to the labeling on the containers and the CoA.
    3. If required regulatory documents are missing or incomplete (e.g., an outdated SDS), immediately quarantine the material and notify Procurement and QA.
  2. Quarantine Labeling

    1. Affix a “Quarantine” label to each container, specifying the date of receipt, batch/lot number, and hazard classification.
    2. Move quarantined containers to a designated, well-ventilated storage area that meets the compatibility requirements for the specific hazardous class (e.g., flammables separated from oxidizers).
  3. Receiving Register Entry

    1. Update the Raw Material Receiving Register (Annexure-1) with essential details: date, supplier, PO number, batch number, quantity, hazard class, and any observed damage or anomalies.
    2. Warehouse Personnel sign or initial each entry to confirm accountability and data integrity.
See also  SOP for Checking Raw Material Shipment against Approved Purchase Order (PO) - V 2.0

5.4 Sampling and Quality Control

  1. Sampling Plan

    1. QC, in consultation with EHS, determines the sampling plan, including the frequency of sampling and test parameters based on risk assessments. Highly toxic or reactive chemicals may require specialized sampling techniques or equipment.
    2. Confirm that the sampling environment is suitable (e.g., a fume hood or well-ventilated area) to mitigate exposure risks.
  2. Sampling Procedure

    1. QC personnel must wear the recommended PPE (e.g., respirators, chemical-resistant gloves, goggles) and follow GMP protocols to prevent contamination.
    2. Take representative samples from the top, middle, and bottom of drums or from multiple points in sacks/containers, as stipulated by the sampling plan.
    3. Record all sampling data (date, sampler’s name, container ID) in the Sampling Log (Annexure-2). Clearly label each sample container with the hazardous material details.
  3. QC Testing

    1. Conduct analytical tests (e.g., assay, pH, impurity levels) and verify the results against the supplier’s CoA and internal specifications. Focus on parameters critical to safety (e.g., water content for reactive materials) and quality (e.g., purity for API-grade substances).
    2. Any out-of-specification (OOS) results or significant deviations must trigger an immediate investigation. QA, QC, and EHS collaborate to assess safety implications and decide whether to reject the material.

5.5 Approval and Release

  1. QA and EHS Review

    1. QA reviews the QC test results and verifies that all necessary documentation (SDS, CoA, permits) is complete and compliant. EHS ensures all safety requirements have been met.
    2. If the material meets the acceptance criteria, QA/EHS jointly approve the material for use or storage, removing the quarantine status.
  2. Release Labeling

    1. Replace quarantine labels with an “Approved” or “Released” label, indicating the date of release and referencing the batch number.
    2. Update the inventory management system to reflect the change in status from “Quarantined” to “Approved,” ensuring traceability for future audits.
  3. Rejection or Special Handling

    1. If the material is rejected due to safety concerns, OOS results, or incorrect documentation, label it “Rejected” and segregate it from approved stock. Follow disposal or return-to-vendor procedures as outlined by EHS and QA.
    2. In cases where materials do not fully meet specifications but can be reprocessed or require special handling, QA and EHS provide written guidelines. Maintain a separate storage area to prevent unauthorized use.

See also  SOP for Handling and Unpacking Large Bulk Material Containers - V 2.0

5.6 Documentation and Record-Keeping

  1. Raw Material Receiving Register

    1. Warehouse Personnel must document all essential information regarding the receipt of hazardous or high-risk materials in the Raw Material Receiving Register (Annexure-1).
    2. Include the material name, supplier, PO number, hazard classification, storage requirements (if critical), and any initial observations about packaging or labeling.
  2. Sampling Log

    1. QC records details of sampling in the Sampling Log (Annexure-2). Ensure each sample is traceable to its original container and all test results or OOS investigations are attached or cross-referenced.
    2. Sign or initial each log entry, adding a date and a reference to the relevant SOP or testing protocol if needed.
  3. Deviation and CAPA Records

    1. Any serious discrepancies in labeling, documentation, or test results require initiation of a deviation record. QA must review, approve, and assign CAPA actions, if necessary.
    2. Maintain all deviation and CAPA records in accordance with regulatory guidelines, ensuring a clear audit trail.
  4. Archiving and Retention

    1. Store records (receiving forms, SDS, CoA, QC results) in a secure area with controlled access for the duration specified by local regulations or company policy (commonly 5 to 7 years or more).
    2. Ensure that any electronic records are backed up regularly and meet data integrity standards (e.g., 21 CFR Part 11, if applicable).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • EHS: Environment, Health & Safety
  • PO: Purchase Order
  • SDS: Safety Data Sheet
  • CoA: Certificate of Analysis
  • CAPA: Corrective and Preventive Action
  • OOS: Out of Specification
  • AVL: Approved Vendor List
  • PPE: Personal Protective Equipment
  • IBC: Intermediate Bulk Container
  • NFPA: National Fire Protection Association
  • GHS: Globally Harmonized System of Classification and Labelling of Chemicals

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
  • OSHA Hazard Communication Standard (29 CFR 1910.1200)
  • REACH Regulation (EC) No 1907/2006 (if applicable)
  • Company-Specific EHS Policies and Procedures

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 Hazard Class PO Number Remarks
01/02/2025 ABC Chemicals Corrosive Acid A Batch CA2025 Corrosive PO-99999 No Damage
02/02/2025 XYZ Global Flammable Solvent B Lot FS-345 Flammable PO-88888 Minor Spill on Pallet

Annexure-2: Sampling Log

Date Material Name Batch Number Sampling Personnel QC Test Performed Result
01/02/2025 Corrosive Acid A Batch CA2025 John Doe Assay, Purity Pass
02/02/2025 Flammable Solvent B Lot FS-345 Jane Smith Flash Point, Purity 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 Establishing SOP for high-risk chemicals
01/02/2025 2.0 Enhanced Procedure Details Standardization of Document QA Head All All Expanded sections on EHS responsibilities and sampling
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