Elixir Department: SOP for Real-Time API Content Verification – V 2.0

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Elixir Department: SOP for Real-Time API Content Verification – V 2.0

Standard Operating Procedure for Real-Time API Content Verification in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/203/2025
Supersedes SOP/ELX/203/2022
Page No. Page 1 of 9
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To define the procedure for performing real-time verification of active pharmaceutical ingredient (API) content during elixir manufacturing using validated analytical methods, ensuring accurate and consistent API concentration before batch progression.

2. Scope

This SOP applies to all elixir batches where in-process API content verification is required post-dissolution and before final blending or volume adjustment. It covers both offline and inline analytical techniques used in real-time process monitoring.

3. Responsibilities

  • Production Operator:
    • Inform QC when the API has been added and ensure proper sampling access.
  • QC Analyst:
    • Collect and analyze in-process samples using validated assay methods.
    • Report deviations from target concentration.
  • QA Officer:
    • Review test data and approve batch continuation based on compliance.
See also  Elixir Department: SOP for Sampling of Final Product for QC - V 2.0

4. Accountability

The QC Head is accountable for timely and accurate analysis. Production Head ensures coordination and sampling integrity. QA Head oversees data review and batch clearance.

5. Procedure

5.1 Sampling and Timing

  1. Collect sample after complete dissolution of API and homogenization of the batch.
  2. Use a clean, dry, amber vial to collect 50 mL from the middle of the tank using a calibrated sampling device.
  3. Label the sample with batch number, time, and “In-Process API Assay.”
  4. Transport sample immediately to QC lab for real-time analysis.

5.2 Analytical Method

  1. Use the validated assay method as per product specification (e.g., UV spectrophotometry or HPLC).
  2. Perform assay in duplicate and calculate the average result.
  3. Ensure system suitability criteria are met before testing (as per SOP/QC/HPLC/002).

5.3 Inline Monitoring (if applicable)

  1. If inline probes are used, ensure they are calibrated and cleaned before use.
  2. Record real-time readings on a data acquisition system linked to the manufacturing tank.
  3. Verify inline data against offline assay results during validation and periodically thereafter.
See also  Elixir Department: SOP for Handling Material Spillage in Dispensing Area - V 2.0

5.4 Acceptance Criteria

  1. API concentration must be within ±5% of the theoretical target value stated in the BMR.
  2. If outside limits, notify Production and QA immediately. Do not proceed until correction and retesting are complete.

5.5 Actions for OOS Results

  1. Review sampling and analytical steps for possible errors.
  2. Repeat test with new sample from same batch location.
  3. If failure is confirmed, initiate deviation report and corrective action plan.

5.6 Documentation

  1. Enter test results in the Real-Time API Assay Logbook (Annexure-1).
  2. Attach raw data printouts, instrument run reports, and analyst worksheet.
  3. Record deviation reports if any, and link them to batch record.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • API: Active Pharmaceutical Ingredient
  • QA: Quality Assurance
  • QC: Quality Control
  • BMR: Batch Manufacturing Record
  • HPLC: High-Performance Liquid Chromatography
See also  Elixir Department: SOP for Identification of Critical vs Non-Critical Materials - V 2.0

7. Documents

  1. Real-Time API Assay Logbook (Annexure-1)
  2. Batch Manufacturing Record (BMR)
  3. Instrument Calibration Certificates

8. References

  • ICH Q2(R1) – Validation of Analytical Procedures
  • 21 CFR Part 211.165 – Testing and Release for Distribution
  • WHO TRS 986 – 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: Real-Time API Assay Logbook

Date Batch No. Sampling Time API Assay (%) Acceptance Criteria Result Tested By QA Review
11/04/2025 ELX-0425-022 10:45 AM 99.2% 95.0 – 105.0% Pass Rajesh Kumar 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 Added inline monitoring provisions and assay verification steps Process Optimization QA Head
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