SOP for Receiving Temperature-Sensitive Raw Materials – V 2.0

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SOP for Receiving Temperature-Sensitive Raw Materials – V 2.0

Standard Operating Procedure for Receiving Temperature-Sensitive Raw Materials

Department Warehouse / Quality Assurance
SOP No. SOP/RM/009/2025
Supersedes SOP/RM/009/2022
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 the requirements and procedures for receiving temperature-sensitive raw materials in a manner that safeguards their quality and integrity. Many raw materials utilized in pharmaceutical, biotechnology, and related industries are vulnerable to temperature excursions during transit or storage, which can degrade efficacy, compromise purity, or alter critical characteristics. By following this SOP, the organization ensures compliance with Good Manufacturing Practices (GMP), mitigates the risk of product spoilage, and maintains a robust system of controls around temperature monitoring and record-keeping.

2. Scope

This SOP applies to all temperature-sensitive raw materials—whether requiring refrigeration, freezing, controlled room temperature, or other specialized temperature conditions—arriving at the facility’s receiving dock or storage areas. It outlines the roles and responsibilities of Warehouse Personnel, Quality Assurance (QA), and any support departments (Quality Control, Procurement, etc.) that handle, approve, or oversee the receipt of such materials. It includes guidelines for preliminary checks, documentation verification, temperature monitoring, quarantine, release, and record-keeping to ensure that these materials remain within their specified temperature range and are fit for use.

3. Responsibilities

  • Warehouse Personnel:
    • Prepare the receiving area to accommodate temperature-sensitive shipments (including coolers, temperature monitoring devices, etc.).
    • Inspect the condition of shipping containers, data loggers, or temperature indicators, and immediately note any anomalies.
    • Record receipt data—date, supplier, purchase order (PO) number—in the Raw Material Receiving Register, with clear notations for any temperature-related deviations.
    • Coordinate with QA for materials that appear compromised or deviate from acceptable temperature ranges.
  • Quality Assurance (QA) Team:
    • Establish acceptable temperature ranges and define protocols for managing excursions.
    • Review receiving documentation (including temperature logger readings) to ensure compliance with internal specifications and regulatory expectations.
    • Authorize final disposition (release, hold, or rejection) of temperature-sensitive raw materials based on risk assessments, data analysis, and any QC findings.
    • Implement corrective actions and continuous improvements if temperature excursions or supplier non-compliance occur repeatedly.
  • Quality Control (QC) Team (If Applicable):
    • Conduct sampling and testing if there is any doubt regarding product integrity due to possible temperature deviations during transit.
    • Advise QA on the results of QC tests that may confirm or disprove material viability after suspected temperature excursions.
  • Procurement Department:
    • Ensure that suppliers are aware of temperature requirements and have adequate shipping protocols in place (e.g., validated packaging, proper labeling, suitable data loggers).
    • Manage supplier performance, addressing repeated temperature-related issues or shipping anomalies in a timely manner.

4. Accountability

The Head of Warehouse Operations is accountable for day-to-day compliance with this SOP and ensuring that all temperature-sensitive items are handled correctly upon arrival. The QA Manager (or delegate) has the final authority to determine if materials should be released, quarantined, or rejected. Any revisions, deviations, or non-conformances to this SOP must be documented, investigated, and approved by QA to uphold GMP standards and regulatory obligations.

5. Procedure

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5.1 Receiving Raw Materials

This section outlines preliminary steps Warehouse Personnel must follow to receive temperature-sensitive raw materials efficiently and in compliance with documented temperature requirements.

  1. Pre-Arrival Coordination

    1. Procurement or the supplier may provide advanced shipment notifications indicating the approximate delivery time and special handling instructions (e.g., “Maintain 2°C–8°C,” or “Keep Frozen”). Ensure readiness by preparing the designated receiving area and verifying that refrigerated or frozen storage units are operational.
    2. Have any required PPE (e.g., insulated gloves) available, along with calibrated temperature measurement devices (infrared thermometers, data loggers, etc.) to check the condition of the arriving materials.
  2. Vehicle Arrival

    1. Upon the delivery vehicle’s arrival, verify that proper labeling or signage is visible (e.g., “Refrigerated Shipment,” “Handle with Care,” or “Do Not Freeze” if appropriate). This ensures the correct transport conditions were likely maintained in transit.
    2. Check for signs of poor handling—such as a non-functional refrigeration unit, cargo doors left open, or obvious container damage—that could compromise the shipment’s temperature.
  3. Offloading

    1. Unload the materials carefully, ensuring minimal exposure time to ambient temperatures if the materials require cold or frozen storage. Use appropriate equipment (e.g., refrigerated dollies, insulated carts) if necessary.
    2. Stage the materials in a transitional holding area with stable conditions (e.g., indoor environment shielded from extreme heat or cold) if immediate movement to cold storage is not possible.

5.2 Visual Inspection and Documentation Verification

Thorough inspection of packaging and documentation is essential to confirm that the materials remained within acceptable temperature limits throughout transit.

  1. Packaging Integrity

    1. Examine shipping containers (coolers, insulated boxes, or cryogenic packaging) for damage, including dents, tears, water stains, or compromised seals. Any suspicious observations must be documented.
    2. Check the presence and condition of coolant packs, dry ice, or other temperature-control media. If these are melted or insufficient, further investigation may be required.
  2. Temperature Data Loggers and Indicators

    1. Confirm the presence of a data logger or temperature indicator within the shipment. If the data logger is missing or not activated, notify QA for an immediate decision on further actions.
    2. Download or review the temperature readings to verify the material stayed within the designated temperature range during transit. If the data shows excursions outside the specified range, place the shipment on hold (see Section 5.4) until QA completes an assessment.
  3. Documentation Check

    1. Match the batch numbers and product descriptions on the supplier’s packing list with the container labels. Ensure any special instructions (e.g., “Store at -20°C”) appear on both documents and container markings.
    2. Verify the Certificate of Analysis (CoA) if provided, ensuring it references the correct batch and includes any relevant stability data specific to temperature sensitivity. Incomplete or missing documentation should be escalated to QA.

5.3 Sampling and Quality Control

If initial checks suggest the raw materials remained within the correct temperature range, Warehouse Personnel may proceed with the usual sampling protocol. However, special procedures or additional testing may be required for shipments with questionable temperature histories.

  1. Sampling Guidelines

    1. QC or QA must verify that sampling does not expose the materials to temperatures outside the recommended range. If sampling is performed, it should occur in a temperature-controlled environment (e.g., a cold room or quickly under laminar flow with minimal exposure time).
    2. For highly sensitive materials (e.g., certain biologics or enzymes), consider specialized sampling containers or continuous temperature monitoring while a sample is drawn.
  2. QC Testing

    1. QC may conduct tests such as potency, purity, or stability assays if there is a concern that temperature excursions might have impacted the material’s quality. Document all sampling activity in the Sampling Log (Annexure-2) to maintain traceability.
    2. Out-of-specification (OOS) results related to temperature-sensitive parameters must be escalated to QA for immediate investigation. Such results may indicate thermal degradation or instability.
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5.4 Quarantine and Labeling

Temperature-sensitive materials must remain in a temperature-controlled quarantine area until QA has reviewed all relevant temperature and quality data. This ensures that no compromised product enters the production chain prematurely.

  1. Quarantine Protocol

    1. Assign a designated, temperature-controlled quarantine area for newly received materials. This area should maintain the same or stricter temperature range required for the material’s storage (e.g., a cold room at 2°C–8°C for refrigerated items).
    2. Affix “Quarantine” labels to all containers, indicating the product name, batch number, date of receipt, and any special storage instructions.
  2. Temperature Monitoring in Quarantine

    1. Maintain continuous monitoring of quarantine storage conditions using calibrated thermometers or automated systems. If an unexpected temperature deviation occurs, notify QA immediately and document the incident.
    2. Check that quarantine logs or digital records accurately reflect the times materials enter or leave this area, preserving a robust audit trail.
  3. Data Review by QA

    1. QA reviews data logger readouts, shipping records, and visual inspection reports to confirm no unacceptable temperature excursions took place.
    2. If questionable temperature data or packaging damage is discovered, QA may choose to hold the material for additional testing or, if necessary, reject it outright to avoid risk to final product integrity.

5.5 Approval and Release

Temperature-sensitive materials that pass inspection, testing, and documentation review can be approved for use; those that fail any criteria are rejected or placed under hold for further investigation or disposal.

  1. QA Decision

    1. Once QA determines the shipment has maintained acceptable temperature controls, QA authorizes the material for release. Warehouse Personnel replace “Quarantine” labels with “Approved” labels, noting the date and QA signature or approval reference.
    2. If QA identifies a substantiated temperature excursion—evidenced by data logger data or an OOS test result—QA may reject the material, marking it as “Rejected” and initiating necessary disposal or return procedures with the supplier.
  2. Documentation Update

    1. Warehouse Personnel must update the Raw Material Receiving Register (Annexure-1) to record the final status (Approved or Rejected), referencing any relevant QA forms or deviation reports.
    2. Procurement may be involved if the material is rejected and a claim or credit is needed from the supplier. Ensure all relevant shipping data and temperature logs are preserved.
  3. Inventory Management

    1. Move approved materials into their designated temperature-controlled storage area. Reflect the updated quantity, location, and batch number in the inventory management system.
    2. Ensure that re-test dates or expiry dates are visible for timely usage, preventing inadvertent use of expired or temperature-compromised stock.

5.6 Documentation and Record-Keeping

Proper documentation underpins GMP compliance and provides traceability for all temperature-sensitive materials. Maintaining thorough records of temperature logs, shipping conditions, and approvals ensures the facility is prepared for regulatory audits and can readily investigate any quality concerns.

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  1. Raw Material Receiving Register

    1. Document critical receipt data—date, time, supplier, product name, batch number, observed temperature, and remarks about packaging—in the Raw Material Receiving Register (Annexure-1).
    2. Indicate whether the shipment passed or failed initial temperature checks and if a data logger was included and properly functioning. Include the data logger identification number if applicable.
  2. Sampling Log

    1. QC or QA must note all samples taken for testing in the Sampling Log (Annexure-2), including the date, reason for sampling, and type of test performed (e.g., potency, microbial limits, stability indicators).
    2. Link each sample to the relevant temperature checks or data logger information to maintain chain-of-custody and rationale for any additional tests.
  3. Deviation and Investigation Records

    1. If a temperature excursion is confirmed or suspected, follow the facility’s deviation procedure. QA logs the incident, performs a risk assessment, and decides whether to reject or re-evaluate the material. This process must be fully documented in a deviation report.
    2. Record any corrective or preventive actions (CAPA) initiated—such as improving shipping routes or requiring updated validated packaging from the supplier. Retain these records for the period mandated by local regulations and internal policies.
  4. Electronic Systems and Backups

    1. If using electronic systems for temperature logging or inventory management, confirm that these systems are validated, secure, and meet data integrity standards (e.g., 21 CFR Part 11 for audit trails and restricted access).
    2. Perform regular system backups and calibrations of temperature sensors. Store data securely so that it remains accessible for internal reviews and external audits.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • PO: Purchase Order
  • CoA: Certificate of Analysis
  • OOS: Out of Specification
  • SDS: Safety Data Sheet
  • CAPA: Corrective and Preventive Action

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 Cold Chain or Temperature-Controlled Handling Procedures
  • Approved Vendor List with Validated Shipping Protocols

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 Temperature Range PO Number Remarks
01/02/2025 ABC Biotech Thermo-Sensitive API Lot TS-001 2°C–8°C PO-56789 No Deviations Found
02/02/2025 XYZ Life Sciences Enzyme Prep Batch EZ-101 -20°C PO-98765 Data Logger Inactive

Annexure-2: Sampling Log

Date Material Name Batch Number Sampling Personnel QC Test Performed Result
01/02/2025 Thermo-Sensitive API Lot TS-001 John Doe Potency, Purity Pass
03/02/2025 Enzyme Prep Batch EZ-101 Jane Smith Assay, Activity Level Pending

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 Defined procedure for receiving temperature-sensitive materials
01/02/2025 2.0 Added Detailed Steps Standardization of Document QA Head All All Expanded quarantine requirements and data logger review process
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