Elixir Department: SOP for Use of Data Loggers for Process Validation – V 2.0

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Elixir Department: SOP for Use of Data Loggers for Process Validation – V 2.0

Standard Operating Procedure for Use of Data Loggers for Process Validation in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/117/2025
Supersedes SOP/ELX/117/2022
Page No. Page 1 of 10
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To define the standardized procedure for the selection, calibration, placement, operation, and data retrieval of data loggers used during process validation in elixir manufacturing. This ensures accurate documentation of critical parameters such as temperature, humidity, and pressure for regulatory compliance and quality assurance.

2. Scope

This SOP applies to all validation activities involving temperature mapping, process monitoring, and environmental parameter recording in the Elixir Department, including mixing, storage, and transfer processes.

3. Responsibilities

  • Validation Executive:
    • Set up, operate, and retrieve data from the data loggers as per protocol.
  • QA Officer:
    • Review logger calibration certificates and approve their use.
    • Review data integrity and approve validation results.
  • Engineering Department:
    • Support installation of loggers and ensure safe placement in designated zones.

See also  Elixir Department: SOP for Headspace Oxygen Level Control - V 2.0

4. Accountability

The Validation Head is accountable for ensuring correct use of data loggers and accurate reporting during process

validation activities.

5. Procedure

5.1 Selection and Calibration

  1. Select validated and GMP-compliant data loggers suitable for the required parameters (e.g., temperature range -20°C to 80°C).
  2. Ensure each data logger is calibrated within the last 12 months and accompanied by a calibration certificate (traceable to national/international standards).
  3. Label loggers with unique IDs and maintain a record in the Data Logger Inventory Log.

5.2 Pre-Validation Setup

  1. Review the Process Validation Protocol to identify the number and location of loggers required.
  2. Place loggers in identified locations such as:
    • Top, middle, and bottom zones of tanks or vessels
    • Inlet and outlet lines
    • Holding rooms, refrigerators, or jacketed vessels
  3. Secure loggers with appropriate holders or adhesive tapes to avoid movement during operation.

5.3 Logger Programming and Deployment

  1. Connect the logger to its software interface and program with:
    • Sampling frequency (e.g., every 1 minute)
    • Start delay (if any)
    • Duration or number of readings
  2. Activate logger recording mode prior to batch startup or equipment operation.
  3. Document logger deployment in the Validation Execution Record.
See also  Elixir Department: SOP for Cleaning of Mixing Vessels Post-Batch - V 2.0

5.4 Monitoring During Operation

  1. Ensure logger placement remains undisturbed during batch operation.
  2. In case of deviation or anomaly in process parameters, log event in the BMR and Validation Execution Record.
  3. If real-time logger display is available, monitor trends for process consistency.

5.5 Data Retrieval and Analysis

  1. After the process completes, retrieve the loggers carefully.
  2. Connect each logger to the software and download data into secure folders on the validated computer system.
  3. Export data into .csv or .pdf formats and save with proper file naming convention: BatchNo_Equipment_Parameter_Date.
  4. Analyze the data using min/max/mean values, graphical trends, and alarm limit assessments.

5.6 Reporting and Documentation

  1. Summarize results in the Validation Summary Report with appropriate graphs and observations.
  2. Attach raw data files, certificates, logger programming screenshots, and deviation forms (if any).
  3. Submit report to QA for review and approval.

5.7 Storage and Maintenance

  1. Store loggers in a clean, dry, and labeled container with silica gel pouches.
  2. Recharge or replace batteries as required.
  3. Send for re-calibration annually or post-impact event (e.g., accidental drop).
See also  Elixir Department: SOP for Calibration of Dispensing Balances - V 2.0

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • BMR: Batch Manufacturing Record
  • CSV: Comma-Separated Values
  • GMP: Good Manufacturing Practice

7. Documents

  1. Data Logger Inventory Log
  2. Validation Execution Record
  3. Validation Summary Report

8. References

  • ICH Q8, Q9, Q10 – Pharmaceutical Development, Quality Risk Management, and Quality Systems
  • 21 CFR Part 11 – Electronic Records and Electronic Signatures
  • WHO TRS 1010 – Process Validation Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Sample Logger Deployment Record

Date Logger ID Location Parameter Start Time End Time Deployed By Retrieved By
11/04/2025 DL-007 Tank T-5 (Bottom) Temperature 08:00 11:45 Rajesh Kumar Sunita Reddy

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Release New SOP QA Head
11/04/2025 2.0 Enhanced to include annexure, digital storage format, and deviation handling GMP Alignment QA Head
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