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

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.

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.

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