SOP Guide for Pharma

Elixir Department: SOP for Homogeneity Verification – V 2.0

Auditor

Elixir Department: SOP for Homogeneity Verification – V 2.0

Standard Operating Procedure for Homogeneity Verification in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/063/2025
Supersedes SOP/ELX/063/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To establish a standardized procedure for verifying the homogeneity of elixir formulations before filtration and packing to ensure uniform distribution of active ingredients and excipients.

2. Scope

This SOP applies to all elixir batches manufactured in the Elixir Department and requires homogeneity verification before the final product transfer for filtration and filling.

3. Responsibilities

  • Production Operator:
    • Collect samples from designated sampling points.
    • Perform visual checks and submit samples to QC for assay or content uniformity.
  • QA Officer:
    • Review sampling practices and verify that homogeneity checks are performed as per SOP.
  • QC Analyst:
    • Conduct analytical testing of samples from different layers (top, middle, bottom).
    • Report variations and approve/reject batch based on specification compliance.
See also  Elixir Department: SOP for Calibration of Weighing Balances Used in Elixir Dispensing - V 2.0

4. Accountability

The Production Head is accountable for ensuring that all homogeneity verification activities are conducted and documented before batch clearance.

5. Procedure

5.1

Sampling for Homogeneity Check
  1. After final mixing and before bulk filtration, stop agitation for 5 minutes to settle bubbles.
  2. Collect samples from three levels of the batch:
    • Top (upper 10%)
    • Middle (center volume)
    • Bottom (last 10%)
  3. Label each sample with location, date, batch number, and collector’s name.

5.2 Visual and Physical Examination

  1. Visually inspect each sample for clarity, color, presence of precipitates, and uniformity.
  2. Note differences in appearance between different layers (if any).

5.3 Analytical Testing

  1. Send samples to QC for:
    • Assay of active ingredients
    • Content uniformity (if required)
  2. Acceptable variation between top, middle, and bottom samples should not exceed ±5% from average assay result or as per specification.

5.4 Acceptance Criteria

  1. Appearance of all three samples should be consistent and free from particulate matter or phase separation.
  2. Assay values of samples must be within limits defined in the product specification sheet.

5.5 Documentation

  1. Record sampling and test results in the Homogeneity Verification Log (Annexure-1).
  2. Attach signed QC report to the BMR for final batch clearance.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • BMR: Batch Manufacturing Record
  • QC: Quality Control
  • QA: Quality Assurance

7. Documents

  1. Homogeneity Verification Log (Annexure-1)
  2. QC Test Report
  3. Batch Manufacturing Record

8. References

  • ICH Q8(R2) – Pharmaceutical Development
  • WHO GMP Guidelines – Section 7: Production

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Homogeneity Verification Log

Date Batch No. Sample Point Appearance Assay (%) Tested By Verified By
11/04/2025 ELX-1009 Top Clear 98.2 Vikram Joshi Sunita Reddy
11/04/2025 ELX-1009 Middle Clear 98.4 Vikram Joshi Sunita Reddy
11/04/2025 ELX-1009 Bottom Clear 98.1 Vikram Joshi Sunita Reddy

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Issuance New SOP QA Head
11/04/2025 2.0 Updated verification points and added assay limits Regulatory Alignment QA Head
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