Elixir Department: SOP for Statistical Trending of IPC Data – V 2.0

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Elixir Department: SOP for Statistical Trending of IPC Data – V 2.0

Standard Operating Procedure for Statistical Trending of In-Process Control (IPC) Data

Department Elixir Department
SOP No. SOP/ELX/210/2025
Supersedes SOP/ELX/210/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To define a systematic approach for the statistical analysis and trending of In-Process Control (IPC) data generated during elixir manufacturing. The objective is to detect variability, identify trends, and ensure process consistency and continuous improvement.

2. Scope

This SOP applies to all IPC data collected during the production of elixirs, including but not limited to pH, weight per mL, API assay, clarity, and viscosity. It includes manual and electronic data trending, review, and reporting practices.

3. Responsibilities

  • QC Analyst:
    • Record IPC data accurately and maintain relevant trend sheets or databases.
  • QA Officer:
    • Review statistical trend reports and investigate deviations or unusual shifts.
  • Data Analyst / QA Executive:
    • Compile, analyze, and interpret monthly IPC data for trend evaluation.
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4. Accountability

The QA Head is accountable for overseeing the IPC data trending process and implementing corrective actions where necessary. The QC Head is

responsible for ensuring timely and accurate data capture.

5. Procedure

5.1 Data Collection

  1. Collect IPC data from:
    • Batch Manufacturing Records (BMRs)
    • IPC logbooks and electronic LIMS systems (if applicable)
  2. Transfer IPC parameters into standardized data entry templates (Annexure-1).
  3. Ensure data entry includes:
    • Batch number
    • Date
    • IPC parameter
    • Observed value

5.2 Statistical Analysis

  1. Use Microsoft Excel or validated statistical software for plotting and analysis.
  2. Generate the following for each parameter:
    • Mean, standard deviation
    • Upper and lower control limits (UCL & LCL)
    • Control charts (X-bar and R charts, if required)
  3. Assess for:
    • Shifts or trends
    • Outliers
    • Process drift or variability

5.3 Frequency of Trending

  1. Perform trending:
    • Monthly – compiled report
    • Quarterly – management summary
    • Annually – trend summary for Product Quality Review (PQR)
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5.4 Review and Reporting

  1. QA shall review trend charts monthly for any excursions.
  2. Any deviation beyond control limits shall be treated as a potential process deviation and reviewed with Production and QC.
  3. Prepare IPC Trending Report (Annexure-2) and submit to QA Head for review and signature.

5.5 Corrective and Preventive Action (CAPA)

  1. Initiate CAPA if:
    • Repeated outliers are observed
    • Control limits are consistently approached
    • Unexpected shifts are seen in trends
  2. Document CAPA in the CAPA register and link to trend reports.

6. Abbreviations

  • IPC: In-Process Control
  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • QC: Quality Control
  • BMR: Batch Manufacturing Record
  • UCL: Upper Control Limit
  • LCL: Lower Control Limit
  • CAPA: Corrective and Preventive Action

7. Documents

  1. IPC Data Entry Template (Annexure-1)
  2. IPC Trending Report (Annexure-2)
  3. CAPA Register (if applicable)
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8. References

  • ICH Q10 – Pharmaceutical Quality System
  • 21 CFR Part 211.180 – Records and Reports
  • WHO TRS 986 – GMP 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: IPC Data Entry Template

Batch No. Parameter Result Test Date Specification Initials
ELX-0425-028 pH 6.8 11/04/2025 6.5 – 7.5 Rajesh Kumar

Annexure-2: IPC Trending Report

Month Parameter Mean Std. Deviation UCL LCL Remarks Reviewed By (QA)
March 2025 pH 6.82 0.09 7.00 6.60 Within Trend Sunita Reddy

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Release New SOP QA Head
11/04/2025 2.0 Enhanced to include CAPA linkage and trend report formats Process Control Improvement QA Head
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