Standard Operating Procedure for Handling Temperature Deviations in Received Materials

Department	Warehouse / Quality Assurance / Quality Control / Procurement
SOP No.	SOP/RM/032/2025
Supersedes	SOP/RM/032/2022
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) defines the process for identifying, documenting, and addressing temperature deviations in materials received at the facility. Temperature-sensitive raw materials, such as pharmaceuticals, chemicals, and biologics, require strict temperature control to maintain their efficacy, stability, and compliance with regulatory standards. The objectives of this SOP are to:

• Ensure timely identification and documentation of temperature deviations in received materials.
• Establish clear guidelines for assessing the impact of temperature excursions on material quality.
• Ensure proper communication with suppliers and internal stakeholders for corrective actions.
• Maintain compliance with Good Manufacturing Practices (GMP) and regulatory requirements regarding the storage and handling of temperature-sensitive materials.

2. Scope

This SOP applies to all temperature-sensitive raw materials received at the facility, including but not limited to Active Pharmaceutical Ingredients (APIs), excipients, vaccines, and other biologics that require storage under specified temperature conditions. The SOP covers:

• Procedures for monitoring and documenting temperature conditions during material receipt.
• Actions to be taken in the event of temperature deviations, including quarantine, testing, and potential rejection.
• Responsibilities of Warehouse, Quality Assurance (QA), Quality Control (QC), and Procurement teams in handling temperature deviations.
• Communication protocols with suppliers regarding temperature deviations and corrective actions.

3. Responsibilities

• Warehouse Personnel:
  • Monitor and document the temperature of received materials using data loggers, temperature indicators, or manual thermometers.
  • Identify and report any temperature deviations to QA and QC immediately.
  • Segregate and quarantine materials with temperature deviations until further evaluation.
  • Record temperature data and deviations in the Raw Material Receiving Register (Annexure-1).
• Quality Assurance (QA) Team:
  • Review temperature deviation reports and assess the potential impact on material quality.
  • Coordinate with QC for additional testing if necessary and decide on the acceptance, rejection, or re-testing of materials.
  • Ensure compliance with GMP and regulatory standards for temperature-sensitive materials.
• Quality Control (QC) Team:
  • Perform necessary testing on materials affected by temperature deviations to assess their integrity and quality.
  • Report test results to QA for final disposition decisions.
• Procurement Department:
  • Ensure that suppliers adhere to temperature control requirements during transportation.
  • Coordinate with suppliers to address temperature deviation issues and implement corrective actions as needed.

4. Accountability

The Warehouse Manager is responsible for ensuring that all received materials are checked for temperature compliance according to this SOP. The QA Manager holds the authority to approve, quarantine, or reject materials based on temperature deviation assessments and QC test results. Any deviations from this SOP must be documented and approved by QA to maintain GMP compliance.

5. Procedure

5.1 Pre-Receipt Preparations

1. Review of Purchase Orders and Shipping Documentation
   1. Procurement provides the warehouse with the purchase order (PO) and supplier documentation specifying the required temperature conditions for the materials.
   2. Ensure that the shipment includes temperature data loggers, temperature indicators, or other monitoring devices as specified in the PO.
2. Inspection Area Preparation
   1. Prepare a receiving area equipped with temperature monitoring devices (thermometers, data loggers) to verify the condition of incoming materials.
   2. Ensure that the receiving area is maintained at a controlled temperature suitable for the temporary holding of sensitive materials.
3. Training for Warehouse Personnel
   1. Ensure all personnel involved in the receipt and inspection of temperature-sensitive materials are trained in identifying temperature deviations and handling procedures.

5.2 Receiving and Temperature Monitoring

1. Unloading and Handling
   1. Unload temperature-sensitive materials promptly using appropriate equipment to prevent prolonged exposure to ambient temperatures.
   2. Minimize the time materials spend outside of temperature-controlled environments during receipt and inspection.
2. Verification of Temperature Monitoring Devices
   1. Check the status of temperature data loggers, indicators, or sensors accompanying the shipment:
      • Ensure that data loggers are functional and properly placed within the shipment.
      • Inspect temperature indicators for color changes or alarms indicating deviations.
   2. Retrieve and review temperature data from loggers immediately upon receipt to identify any deviations from specified temperature ranges.

5.3 Documentation and Segregation

1. Recording in Raw Material Receiving Register
   1. Enter all relevant temperature data in the Raw Material Receiving Register (Annexure-1), including:
      • Date of receipt and supplier name.
      • Material name, batch number, and quantity.
      • Recorded temperature data and any identified deviations.
   2. Document any discrepancies or deviations in the remarks section of the register.
2. Quarantine and Labeling
   1. Label materials based on temperature compliance:
      • “Hold” for materials within specified temperature ranges.
      • “Quarantine” for materials with temperature deviations, pending QA review.
      • “Rejected” for materials with significant temperature excursions confirmed to affect quality.
   2. Store materials in designated areas under controlled temperature conditions until QA makes a final decision.

5.4 QA Review and QC Testing

1. QA Review of Temperature Data and Documentation
   1. QA reviews the temperature data retrieved from the shipment, along with supplier documentation, to assess compliance with specified storage conditions.
   2. For materials flagged as “Quarantine,” QA performs a secondary review to determine the potential impact of temperature deviations on material quality.
2. QC Sampling and Stability Testing
   1. If QA suspects that a temperature deviation may have compromised material integrity, QC performs stability or potency testing according to the company’s Sampling SOP (Annexure-2).
   2. Document test results and communicate findings to QA for final disposition.

5.5 Final Disposition

1. Acceptance
   1. Materials that pass QA review and QC testing are labeled “Accepted” and moved to appropriate storage conditions.
   2. Update the Raw Material Receiving Register to reflect the accepted status and ensure traceability.
2. Rejection
   1. Materials that fail QA review or QC testing due to temperature deviations are labeled “Rejected” and moved to the designated rejection area.
   2. Document the reason for rejection in the receiving register and initiate a non-conformance report.
3. Supplier Notification and Corrective Action
   1. Procurement contacts the supplier to report temperature deviation issues and coordinates returns, replacements, or corrective actions.
   2. Document all communications with the supplier, including any changes to shipping and temperature control protocols.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• PO: Purchase Order

7. Documents

1. Raw Material Receiving Register (Annexure-1)
2. Sampling Log (Annexure-2)
3. Purchase Orders (PO), Supplier Invoices, and Shipping Documentation
4. Temperature Data Logs and Deviation Reports
5. Certificates of Analysis (CoAs)

8. References

• 21 CFR Part 211 – Current GMP for Finished Pharmaceuticals (US FDA)
• EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• Company-Specific Procurement, QA, and Warehouse Policies

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	Quantity	Temperature Data	Remarks
01/02/2025	ABC Chemicals	API-X	X-2025-001	PO-12345	50 kg	2-8°C (Compliant)	Accepted
02/02/2025	XYZ Pharma	Temperature-Sensitive Excipient-Y	Y-2025-002	PO-67890	100 kg	Exceeded 8°C for 4 hours	Quarantined, Pending QC Test

Annexure-2: Sampling Log

Date	Material Name	Batch Number	Sampling Personnel	QC Test Performed	Result	Remarks
01/02/2025	API-X	X-2025-001	John Doe	Potency Test	Pass	Approved for Use
03/02/2025	Excipient-Y	Y-2025-002	Jane Smith	Stability Test	Fail	Rejected Due to Temperature Deviation

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 procedures for handling temperature deviations in received materials.
01/02/2025	2.0	Enhanced Monitoring and Corrective Actions	Standardization of Document	QA Head	All	All	Added detailed guidelines for data logger analysis and supplier communication.