Capsule: SOP for Inline QC Testing During Capsule Manufacturing – V 2.0

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Capsule: SOP for Inline QC Testing During Capsule Manufacturing – V 2.0

Standard Operating Procedure for Inline QC Testing During Capsule Manufacturing

Department Capsule Manufacturing
SOP No. SOP/CM/102/2025
Supersedes SOP/CM/102/2022
Page No. Page 1 of 6
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to define the procedure for conducting inline quality control (QC) testing during the capsule manufacturing process. Inline QC testing ensures that capsule manufacturing processes are continuously monitored for product quality, compliance with specifications, and adherence to Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to the capsule manufacturing process where inline QC testing is implemented. It includes the monitoring of critical quality attributes, including size, weight, fill volume, and appearance, as well as the detection of deviations from quality standards.

3. Responsibilities

  • Production Operators: Responsible for conducting inline QC tests during the manufacturing process and ensuring that test results meet the required specifications.
  • Quality Control (QC) Team: Responsible for reviewing inline test results, verifying compliance, and taking appropriate actions for deviations detected during manufacturing.
  • Quality Assurance (QA) Team: Ensures that the inline QC testing procedures are followed in compliance with GMP and regulatory requirements.
  • Production Supervisor: Responsible for overseeing the inline QC testing process, ensuring that the tests are conducted properly, and troubleshooting any issues that arise during testing.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that inline QC tests are conducted as per the SOP. The QA Manager is responsible for reviewing the inline testing results and ensuring compliance with GMP and regulatory requirements.

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5. Procedure

5.1 Inline QC Testing Parameters

Before initiating inline QC testing, the following parameters should be defined:

  1. Determine Quality Attributes

    1. Identify critical quality attributes for capsule production, including size, weight, fill volume, appearance, and integrity.
    2. Establish acceptable limits for each attribute based on product specifications and regulatory requirements.
  2. Set Test Frequency

    1. Determine the frequency of inline QC testing based on batch size, production speed, and criticality of the quality attributes being monitored.
    2. Set testing intervals to ensure adequate sampling and monitoring throughout the production run.

5.2 Setting Up Inline QC Testing Equipment

To ensure accurate inline testing, ensure that the necessary equipment is properly set up:

  1. Verify Calibration of Equipment

    1. Before testing, ensure that the inline QC testing equipment is properly calibrated to measure parameters such as capsule weight, size, and fill volume.
    2. Use calibrated test instruments and verify the calibration regularly to maintain testing accuracy.
  2. Check Equipment Condition

    1. Ensure that all equipment used for inline testing is clean, properly maintained, and functioning as intended.
    2. Inspect sensors, cameras, or other monitoring devices used in inline QC to ensure they are working properly without obstructions.

5.3 Performing Inline QC Testing During Capsule Manufacturing

Once the equipment is set up, proceed with the inline QC testing process:

  1. Monitor Capsule Attributes

    1. Monitor critical capsule attributes such as size, weight, fill volume, and appearance at regular intervals during the manufacturing process.
    2. Use inline measurement systems or automated machines to capture data on capsule attributes.
  2. Document Test Results

    1. Record the results of each inline QC test in the Inline QC Testing Log (Annexure-1), including test parameters, date, time, and any deviations from the specified limits.
    2. Ensure that all data is signed, dated, and reviewed by a responsible person to maintain traceability and accountability.
  3. Analyze Test Data

    1. Analyze the collected data to determine if the capsules meet the required quality standards.
    2. Track trends over time to identify any patterns that could indicate deviations or issues with the manufacturing process.
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5.4 Handling Deviations in Inline QC Testing

If any deviations or out-of-spec results are detected during inline QC testing, follow these steps:

  1. Identify the Cause of Deviation

    1. Investigate the cause of the deviation by reviewing the process, materials, equipment, and environmental conditions.
    2. Consult with the production team to determine if the deviation is related to equipment malfunction, process variation, or raw material issues.
  2. Implement Corrective Actions

    1. Take corrective actions based on the identified cause, such as adjusting equipment settings, changing materials, or modifying the manufacturing process.
    2. Re-test the affected capsules to ensure that the corrective actions have successfully resolved the deviation.
  3. Record Deviation and Corrective Actions

    1. Document all deviations, corrective actions, and retesting results in the Deviation Log (Annexure-2) to maintain a record for future audits or inspections.

5.5 Quality Control Review and Final Approval

Once the inline QC testing is complete, follow these steps:

  1. QA Review of Test Results

    1. The QA team should review the results of the inline QC testing, ensuring that all capsules meet the required quality standards.
    2. Ensure that any deviations were properly addressed and documented.
  2. Approval for Next Production Step

    1. If the inline QC testing results are satisfactory, approve the batch to proceed to the next manufacturing step or packaging.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • BPR: Batch Production Record

7. Documents

  1. Inline QC Testing Log (Annexure-1)
  2. Deviation Log (Annexure-2)
  3. Batch Production Record (BPR) (Annexure-3)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • Good Manufacturing Practice (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: Inline QC Testing Log

Sample ID Test Parameter Test Result Deviation Corrective Action Taken Operator
Sample 001 Capsule Weight 500 mg No None John Doe
Sample 002 Fill Volume Standard No None Jane Smith

Annexure-2: Deviation Log

Deviation ID Batch ID Description Corrective Action Operator Approval Status
DEV-001 Batch 001 Capsule weight outside acceptable range Recalibrated filling machine and adjusted speed John Doe Approved

Annexure-3: Batch Production Record (BPR)

Batch ID Capsule Weight Fill Volume Inspection Results Corrective Actions
Batch 001 500 mg Standard Pass None

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Creation QA Head
01/02/2025 2.0 Updated inline QC testing procedures Standardization QA Head
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