The Role of IPQA in Pharmaceutical Production: Essential Checks and Procedure

The Role of IPQA in Pharmaceutical Production: Essential Checks and Procedures

Introduction: In the pharmaceutical industry, maintaining quality at every production stage is critical to ensure the safety and efficacy of products. In-Process Quality Assurance (IPQA) is a systematic approach that helps achieve this goal. This blog explores the key steps and innovative strategies to implement effective IPQA in pharmaceutical production.

Key Steps of IPQA:

1. Area Verification:

   • Verify the area label with the process.

   • Ensure line clearance is done.

   • Maintain cleaning and operating records.

2. Equipment and Documentation:

   • Verify the status label of equipment with the process stage.

   • Verify activities in accordance with SOPs and instructions in BMR and BPR.

   • Verify timely completion of batch documents.

3. Personnel Practices:

   • Verify personnel practices, including gowning.

4. Environmental Controls:

   • Verify pressure differential of areas within limits on the Magnehelic gauge.

   • Verify temperature and relative humidity levels.

5. Calibration and Records:

   • Verify status labels where relevant.

   • Verify calibration status and records of balances.

6. Compliance Checks:

   • Verify rinse/swab reports in BMR.

   • Perform IPQA checks as per frequency defined in BMR.

   • Enclose bulk release COA in BMR.

7. Incident Reporting:

• Report any incident or deviation observed.

  
  
  

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