Capsule: SOP for Handling Rejected Capsules During Manufacturing – V 2.0

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Capsule: SOP for Handling Rejected Capsules During Manufacturing – V 2.0

Standard Operating Procedure for Handling Rejected Capsules During Manufacturing

Department Capsule Manufacturing
SOP No. SOP/CM/067/2025
Supersedes SOP/CM/067/2022
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 handling rejected capsules during the manufacturing process. Rejected capsules must be properly identified, segregated, and disposed of or reworked in accordance with established procedures to maintain product quality and comply with regulatory standards.

2. Scope

This SOP applies to all capsule manufacturing processes where capsules are rejected due to quality issues, such as defects in filling, sealing, weight, or appearance. It includes the steps for segregation, documentation, and disposal or rework of rejected capsules.

3. Responsibilities

  • Manufacturing Team: Responsible for identifying and segregating rejected capsules during production, ensuring that they are handled as per this SOP.
  • Quality Control (QC) Team: Responsible for inspecting rejected capsules, determining the cause of rejection, and ensuring that rejected capsules are disposed of or reworked as appropriate.
  • Quality Assurance (QA) Team: Ensures that rejected capsules are handled according to SOP, investigates root causes of rejection, and ensures compliance with GMP regulations.
  • Maintenance Team: Ensures that any equipment or machine malfunctions contributing to capsule rejection are promptly addressed and documented.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the rejected capsules are properly handled, segregated, and documented. The QA Manager is responsible for overseeing the rejection handling process and ensuring that all deviations are investigated and addressed appropriately.

5. Procedure

5.1 Identification of Rejected Capsules

During the manufacturing process, capsules may be rejected due to various reasons such as defects in fill weight, misalignment, sealing issues, or other quality problems. The following steps should be followed to identify rejected capsules:

  1. Routine Inspections

    1. Conduct visual inspections and quality checks at regular intervals throughout the production process to identify defective capsules. Inspections should focus on visual defects, improper fill, damaged capsules, and other obvious issues.
  2. Sampling

    1. Perform sample checks to detect potential defects. Rejected capsules should be marked immediately upon detection.
  3. Defects to Look for

    1. Cracked or damaged shells
    2. Improperly filled or empty capsules
    3. Poorly sealed capsules
    4. Discoloration or contamination
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5.2 Segregation of Rejected Capsules

Once capsules are identified as rejected, the following steps should be taken:

  1. Immediate Segregation

    1. Immediately separate rejected capsules from the acceptable batch to prevent contamination or mixing with good capsules. Use designated bins or containers clearly marked as “Rejected” to segregate the defective capsules.
  2. Labeling and Documentation

    1. Label the rejected capsules with the reason for rejection and batch number. Maintain records of rejected capsules, including the quantity and specific defect type. This should be documented in the batch production record and in a separate rejection log.
  3. Regular Inspection

    1. Ensure that the rejected capsules are inspected regularly to prevent further contamination or mismanagement. Maintain clear separation between rejected and non-rejected capsules in the storage area.

5.3 Investigation of Rejected Capsules

If a significant number of capsules are rejected, a thorough investigation should be conducted to determine the root cause of the problem:

  1. Root Cause Analysis

    1. Perform a root cause analysis to identify the underlying issue that caused the rejection. Common causes could include equipment malfunction, improper formulation, or human error.
  2. Corrective Action

    1. Based on the investigation, take corrective actions to address the root cause. This may include equipment calibration, adjustments to machine settings, improved operator training, or changes to the raw materials.
  3. Rework or Rejection

    1. Once the issue is identified and corrected, evaluate the rejected capsules to determine if they can be reworked or if they need to be discarded. For reworkable capsules, establish the process for reworking them to meet the required quality standards.
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5.4 Disposal of Rejected Capsules

Once the rejection process is complete, the capsules must be properly disposed of if they cannot be reworked:

  1. Segregation for Disposal

    1. Rejected capsules that cannot be reworked must be segregated for disposal. Place them in sealed containers and ensure that they are not accessible to production or quality control personnel.
  2. Disposal Methods

    1. Ensure that the disposal of rejected capsules complies with environmental and safety regulations. Use approved disposal methods, such as incineration or disposal at certified waste management facilities.
  3. Document Disposal

    1. Document the disposal of rejected capsules, including the quantity, reason for rejection, and disposal method. Ensure the record is kept for future reference and audit purposes.

5.5 Rework of Rejected Capsules

If the rejected capsules are reworkable, ensure the following steps are followed:

  1. Rework Identification

    1. Determine if the rejected capsules can be reworked without compromising their quality or integrity. Common rework actions include refilling, resealing, or relabeling capsules.
  2. Rework Process

    1. Follow the appropriate procedure for reworking the capsules. Document each step of the rework process, including adjustments made to the machine settings or formulation.
  3. Re-inspection

    1. After rework, re-inspect the capsules to ensure that they meet the required quality specifications. Perform visual and weight checks to confirm that the capsules are now acceptable.

5.6 Documentation and Record-Keeping

Proper documentation is crucial for the traceability of rejected capsules:

  1. Rejection Log

    1. Maintain a log of all rejected capsules, including the batch number, reason for rejection, and corrective actions taken. This log should be reviewed periodically for any trends or recurring issues.
  2. Batch Production Records

    1. Document all rejection details in the batch production record, including the number of rejected capsules, reasons for rejection, and the actions taken to address the issue.
  3. Deviation Reports

    1. For significant deviations, document a formal deviation report that includes a root cause analysis, corrective actions, and any impact on product quality.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance

7. Documents

  1. Rejected Capsule Report (Annexure-1)
  2. Deviation and Corrective Action Report (Annexure-2)
  3. Rework Documentation Log (Annexure-3)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • International Conference on Harmonization (ICH) Guidelines for Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Rejected Capsule Report

Batch ID Capsule Size Rejection Date Reason for Rejection Quantity Rejected Action Taken
Batch 001 Hard Gelatin 01/02/2025 Underfilled 100 Reworked

Annexure-2: Deviation and Corrective Action Report

Deviation ID Description Corrective Action Taken Action Taken By
DR-001 Underfilled Capsules Adjusted fill material flow rate Manufacturing Supervisor

Annexure-3: Rework Documentation Log

Batch ID Rework Action Rework Date Reworked Quantity Operator Name
Batch 001 Refilled capsules 02/02/2025 100 John Doe

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 rejection handling criteria Standardization QA Head
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