SOP Guide for Pharma

Elixir Department: SOP for Time-Based Sampling Schedule – V 2.0

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Elixir Department: SOP for Time-Based Sampling Schedule – V 2.0

Standard Operating Procedure for Time-Based Sampling Schedule During Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/204/2025
Supersedes SOP/ELX/204/2022
Page No. Page 1 of 9
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To establish a standardized procedure for implementing and documenting a time-based sampling schedule during the elixir manufacturing process to ensure compliance with Good Manufacturing Practices (GMP) and enable timely process control.

2. Scope

This SOP is applicable to all in-process time-based sampling performed during elixir manufacturing, including sampling for physical, chemical, and microbiological testing at defined intervals.

3. Responsibilities

  • Production Operator:
    • Ensure timely coordination and accessibility for sample collection.
  • QC Analyst:
    • Collect, label, and test samples as per schedule.
    • Maintain accurate records of sampling times and results.
  • QA Officer:
    • Verify sampling adherence and review results for compliance.

4. Accountability

The QC Head is accountable for execution and accuracy of the schedule. The Production Head ensures sampling access. QA ensures documentation integrity and regulatory compliance.

See also  Elixir Department: SOP for Segregation of Quarantined and Approved Materials - V 2.0

5. Procedure

5.1 Establishment of Sampling Schedule

  1. Prepare a
sampling plan during batch planning based on:
  • Critical process steps (e.g., mixing, dissolution, heating, cooling)
  • Process duration
  • Regulatory and internal quality requirements
  • Define exact sampling intervals (e.g., every 15 min, 30 min, 1 hour) and sample types.
  • Document in the Time-Based Sampling Schedule Sheet (Annexure-1) and attach to BMR.

    • 5.2 Sampling Execution

    1. Collect samples at predefined times using clean and labeled containers.
    2. Sampling must be carried out in the order listed in the schedule.
    3. Label each sample with:
      • Product name
      • Batch number
      • Sampling time
      • Sampling point
      • Type of test (e.g., pH, assay, microbial)
    4. Immediately transfer samples to the QC laboratory under appropriate conditions (e.g., temperature).

    5.3 Testing and Evaluation

    1. Analyze samples for:
      • pH
      • API content
      • Appearance and clarity
      • Conductivity
      • Microbial limits (as applicable)
    2. Record test results against each time point in the logbook.
    3. Any deviation or trend indicating instability or abnormality must be reported immediately to QA and Production.

    5.4 Deviation Handling

    1. Missed or delayed sampling must be documented with justification.
    2. Initiate deviation report if sampling is missed or time exceeded by more than ±10% of the scheduled time.

    5.5 Documentation

    1. Maintain a Time-Based Sampling Logbook (Annexure-2) for each batch.
    2. Attach analytical data and QA review sheets to the BMR.

    6. Abbreviations

    • SOP: Standard Operating Procedure
    • QA: Quality Assurance
    • QC: Quality Control
    • BMR: Batch Manufacturing Record
    • API: Active Pharmaceutical Ingredient

    7. Documents

    1. Time-Based Sampling Schedule Sheet (Annexure-1)
    2. Time-Based Sampling Logbook (Annexure-2)
    3. Batch Manufacturing Record (BMR)

    8. References

    • ICH Q8 – Pharmaceutical Development
    • 21 CFR Part 211.110 – In-Process Sampling and Testing
    • WHO TRS 986 – Annex 2: GMP for Pharmaceutical Products

    9. SOP Version

    Version: 2.0

    10. Approval Section

    Prepared By Checked By Approved By
    Signature
    Date
    Name
    Designation
    Department

    11. Annexures

    Annexure-1: Time-Based Sampling Schedule Sheet

    Sampling Time Test Location Sample Collected By QC Received Time Remarks
    10:00 AM pH Mixing Tank Rajesh Kumar 10:15 AM Within range

    Annexure-2: Time-Based Sampling Logbook

    Date Batch No. Sampling Point Test Performed Result Tested By QA Verified
    11/04/2025 ELX-0425-023 Middle Layer API Assay 98.6% Sunita Reddy Manoj Sharma

    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 Added justification for missed sampling & tighter time limits GMP Enhancement QA Head
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