SOP for Handling Materials Requiring Cold Chain Transportation – V 2.0

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SOP for Handling Materials Requiring Cold Chain Transportation – V 2.0

Standard Operating Procedure for Handling Materials Requiring Cold Chain Transportation

Department Warehouse / Quality Assurance
SOP No. SOP/RM/010/2025
Supersedes SOP/RM/010/2022
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 standardized, GMP-compliant process for receiving, handling, and storing raw materials that require cold chain transportation. Cold chain materials typically demand strict temperature control—commonly at refrigerated (2–8°C), frozen (≤ -20°C), or ultra-low temperatures—to maintain their quality, safety, and efficacy. By adhering to this SOP, the organization ensures the integrity of cold chain materials is preserved throughout transit, receipt, quarantine, and storage processes, minimizing the risk of product degradation, spoilage, or regulatory non-compliance.

2. Scope

This SOP covers all cold chain raw materials delivered to the facility, including but not limited to APIs (Active Pharmaceutical Ingredients), excipients, and other temperature-sensitive materials that require refrigerated or frozen conditions. It addresses the roles of Warehouse Personnel, Quality Assurance (QA), Quality Control (QC), Procurement, and any other departments involved in receiving and managing these materials. The guidelines encompass documentation reviews, temperature monitoring, sampling (if required), quarantine procedures, and final disposition (approval or rejection).

3. Responsibilities

  • Warehouse Personnel:
    • Prepare the receiving area to maintain appropriate temperature conditions (e.g., refrigerated docks or insulated areas) for unloading cold chain materials.
    • Check shipping containers, temperature loggers, and any coolant packs or dry ice for adequacy and integrity.
    • Record all pertinent information in the Raw Material Receiving Register, highlighting any temperature deviations or container damage.
    • Immediately notify QA of any suspected temperature excursions, packaging anomalies, or missing documentation.
  • Quality Assurance (QA) Team:
    • Establish and update internal temperature range requirements, acceptance criteria, and procedures for cold chain material handling.
    • Review temperature records, shipping documents, and data logger printouts to verify compliance with specified conditions.
    • Decide on final disposition (release, quarantine, or rejection) based on compliance with temperature protocols, test results, and supplier documentation.
    • Initiate corrective and preventive actions (CAPA) for any major discrepancies or repeated temperature-related deviations.
  • Quality Control (QC) Team (If Applicable):
    • Perform sampling and testing if there is reason to believe temperature excursions might have compromised the material.
    • Communicate all test outcomes, especially out-of-specification (OOS) results, to QA for further investigation or material disposition decisions.
  • Procurement Department:
    • Contract with suppliers who can demonstrate validated cold chain shipping methods and packaging solutions.
    • Ensure Purchase Orders (POs) state the required shipping and storage temperatures, appropriate data logging devices, and acceptance criteria.
    • Follow up with suppliers if repeated temperature excursions occur or if shipping documents are incomplete.
  • Safety and Compliance Officers (If Applicable):
    • Provide guidelines on handling frozen carbon dioxide (dry ice) or other cooling agents to prevent accidents, exposure risks, or fire hazards.
    • Verify compliance with local regulations regarding the use and disposal of coolants, dry ice, or liquid nitrogen.

4. Accountability

The Warehouse Manager is accountable for ensuring the correct implementation of cold chain handling procedures during the receiving process. The QA Manager holds final authority for approving or rejecting materials based on adherence to cold chain requirements and test results. Any modifications, deviations, or non-conformances must be recorded and investigated per the organization’s deviation management system. Procurement is accountable for addressing supplier issues related to cold chain shipping, while any safety concerns involving cryogenics or specialty cooling agents fall under the purview of Safety and Compliance Officers.

See also  SOP for Physical and Visual Inspection of Incoming Raw Materials - V 2.0

5. Procedure

5.1 Pre-Receipt Preparations

  1. Facility and Equipment Readiness

    1. Ensure the designated receiving area for cold chain materials is pre-cooled or equipped to handle low-temperature shipments. This may include refrigerated docks, insulated staging areas, or specialized freezers.
    2. Verify that temperature monitoring equipment (e.g., infrared thermometers, data loggers, or thermocouples) is calibrated, functional, and readily accessible for immediate checks upon material arrival.
    3. Check that Personal Protective Equipment (PPE)—insulated gloves, goggles, lab coats, face shields (if required)—is available to prevent cold burns or chemical exposure from coolant packs or dry ice.
  2. Communication with Supplier

    1. Procurement should provide advanced notice of an incoming cold chain shipment to Warehouse Personnel, specifying the product name, PO number, and recommended storage temperature range (e.g., 2°C–8°C, -20°C, or below -70°C).
    2. Obtain shipping documents (invoices, packing lists, or CoAs) electronically if possible, so the Warehouse team can plan to handle specialized materials promptly upon arrival.

5.2 Receipt of Cold Chain Shipments

Upon arrival, shipments should be rapidly offloaded and placed in a suitable environment to maintain their required temperature range.

  1. Unloading and Initial Checks

    1. Use pallet jacks, trolleys, or forklifts designed for cold chain materials if handling large or palletized loads. Minimize exposure to ambient temperature.
    2. Observe external packaging for signs of damage, condensation, or meltdown of cooling agents. If you notice leaking coolant, dryness where dryness is not expected, or severely damaged containers, escalate to QA.
  2. Data Logger Verification

    1. Check each shipment for a temperature recorder or data logger. If missing or non-functional, mark the consignment as “Quarantined—Temperature Data Missing” and inform QA immediately.
    2. Download or inspect the data logger’s readouts if it has a visual display or USB connectivity. Confirm that the recorded temperature remained within the specified range throughout transit.
    3. If the temperature range was exceeded at any point, note the duration and magnitude of the excursion. Document these details in the Raw Material Receiving Register under “Remarks” and proceed with a QA notification.
  3. Quick Transfer to Staging Area

    1. Move each container into a temperature-controlled staging area (e.g., a cold room or freezer) without delay, ensuring that you do not break the cold chain. If immediate transfer is not feasible, use mobile refrigerated units or thermal blankets to maintain conditions temporarily.
    2. Label or segregate shipments with visible anomalies or suspected excursions for subsequent QA evaluation (see Section 5.4).

5.3 Visual Inspection and Documentation Verification

Next, perform a more detailed inspection of each container and validate the supporting documentation to ensure all materials match the Purchase Order and the established cold chain protocols.

  1. Packaging Integrity

    1. Open one container (or more, as required by QA sampling plans) carefully to check the state of ice packs, dry ice, or other cooling media. Document any partial or complete meltdown if it might indicate time out of range.
    2. Verify container seals, tamper-evident tapes, or adhesives are intact. Broken seals or resealed packaging can suggest a possible compromise during transit.
  2. Label Accuracy

    1. Confirm that the container labels match the product name, batch number, and recommended storage temperature stated on the shipping documents and PO. If there is a mismatch (e.g., label indicates 2°C–8°C, while the PO states -20°C), escalate to QA immediately.
    2. Check expiration dates or re-test dates on the labels. Materials nearing or past their expiry may require additional QA review before acceptance.
  3. Document Cross-Check

    1. Match the batch or lot numbers on the container labels to the supplier’s packing list and any CoAs provided. Confirm that the quantity received aligns with the PO.
    2. Log all identified discrepancies (e.g., missing CoA, incorrect batch number) in the Raw Material Receiving Register and notify QA. Minor clerical issues may be addressed by clarifying with the supplier, while major discrepancies could warrant material quarantine.
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5.4 Quarantine and Labeling

Until QA has confirmed materials meet the prescribed temperature and quality criteria, cold chain shipments remain in a designated quarantine area.

  1. Quarantine Storage

    1. Store quarantined materials in an area that matches their required temperature range (e.g., refrigeration at 2–8°C or a dedicated freezer). Ensure the area is clearly marked as “Quarantine” to prevent unauthorized usage.
    2. Record the date of receipt, supplier name, batch number, and any relevant “Under Investigation” notes on the quarantine label or tag. Keep a record of all quarantined materials in a centralized log or electronic system.
  2. Temperature Monitoring in Quarantine

    1. Implement continuous or scheduled temperature checks of the quarantine environment (e.g., data loggers, probes, or manual readings). If the quarantine zone experiences a deviation, promptly notify QA, as it may compromise multiple batches.
    2. Document these checks in the facility’s temperature monitoring system or logs, retaining the data for the period mandated by local regulations or internal policies.
  3. QA Evaluation

    1. QA reviews data logger printouts, CoAs, and any relevant shipping information to determine whether the materials remained within the acceptable temperature window. If no red flags appear, QA can proceed with final checks before approving release.
    2. In cases of suspected or confirmed temperature excursions, QA may request additional QC tests (e.g., potency, pH, microbial load) to confirm the material’s integrity. Depending on the severity of the excursion, the material could be rejected outright or placed on extended hold for further investigation.

5.5 Approval and Release

After QA confirms the shipment has maintained proper cold chain conditions and the material meets internal specifications, it can be officially released for use or further storage.

  1. Final QA Review

    1. QA signs off on the release if all temperature and documentation requirements are satisfied. This may include verifying test results, checking the container’s labels, or referencing any supplier clarifications.
    2. If QA deems the material compromised (e.g., repeated temperature spikes, physically damaged packaging, or questionable test results), it is rejected and segregated from usable inventory. Procurement is alerted to negotiate returns or credits with the supplier.
  2. Label Replacement and Inventory Update

    1. Replace “Quarantine” labels with “Approved” labels or markings. Ensure each container has visible references to batch numbers, storage conditions, and expiry dates to maintain traceability.
    2. Update the inventory management system to reflect the material’s new status, location (e.g., standard cold room or freezer), and available quantity. Note any special handling or re-test intervals required by QA.
  3. Rejection Process

    1. Rejected materials must be clearly labeled as “Rejected” and removed from the normal cold storage area to prevent accidental usage. These may be sent back to the supplier or disposed of according to local regulations and company policies.
    2. Complete all relevant documentation (e.g., deviation or non-conformance report) to maintain a clear audit trail. Attach temperature logger data, photos, and any email correspondence regarding the rejection.
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5.6 Documentation and Record-Keeping

  1. Raw Material Receiving Register

    1. Enter essential details—date of receipt, product name, batch number, temperature range, observed conditions, data logger status—into the Raw Material Receiving Register (Annexure-1).
    2. Each entry should include the signature or initials of the Warehouse Personnel conducting the inspection, reinforcing accountability and traceability.
  2. Sampling Log

    1. If QC sampling is carried out, document the date, quantity sampled, sampling personnel’s name, and test parameters in the Sampling Log (Annexure-2). Cross-reference the relevant batch number and temperature data as needed.
    2. Maintain test results in a secure, easily retrievable format for internal reviews or regulatory audits.
  3. Deviation and CAPA Records

    1. Major discrepancies—such as data logger failures, large temperature excursions, or incomplete shipping documents—must be filed in a formal deviation record. QA conducts an investigation, implementing corrective or preventive measures as necessary.
    2. Procurement or QA may collaborate with the supplier to address root causes (e.g., inadequate packaging or insufficient coolant) through CAPA plans, ensuring improvements in future shipments.
  4. Retention and Archiving

    1. Preserve all documentation—receiving records, temperature logs, CoAs, data logger printouts, deviation reports, etc.—for the duration specified by local regulatory requirements and company policy.
    2. Store both physical and electronic records in a secure manner with controlled access and periodic backups to prevent data loss or unauthorized modifications.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • PO: Purchase Order
  • API: Active Pharmaceutical Ingredient
  • OOS: Out of Specification
  • CoA: Certificate of Analysis
  • PPE: Personal Protective Equipment
  • 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 Handling Protocols and Guidelines
  • Approved Vendor List (AVL) with Validated Shipping Methods

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 CoolTrans Logistics Cryo-API Alpha Lot CA-222 ≤ -70°C PO-12345 Data Logger Verified
02/02/2025 BioFreeze Inc. Refrigerated Enzyme B Batch EB-567 2°C–8°C PO-67890 Dry Ice Partially Melted

Annexure-2: Sampling Log

Date Material Name Batch Number Sampling Personnel QC Test Performed Result
01/02/2025 Cryo-API Alpha Lot CA-222 John Doe Potency, Purity Pass
03/02/2025 Refrigerated Enzyme B Batch EB-567 Jane Smith Enzymatic Activity, pH 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 baseline procedure for cold chain materials
01/02/2025 2.0 Procedure Update Standardization of Document QA Head All All Expanded guidelines for data logger verification and dry ice handling
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