Capsule: SOP for Handling Overfilled or Underfilled Capsules – V 2.0

Auditor

2 weeks ago

Standard Operating Procedure for Handling Overfilled or Underfilled Capsules

Department	Capsule Manufacturing
SOP No.	SOP/CM/061/2025
Supersedes	SOP/CM/061/2022
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 outline the procedures for identifying and handling overfilled or underfilled capsules during the manufacturing process. This ensures that all capsules meet the required fill weight specifications, maintaining the quality and integrity of the final product.

2. Scope

This SOP applies to all capsule manufacturing operations where capsules are filled with material. It covers the identification, segregation, and appropriate corrective actions for overfilled or underfilled capsules to ensure quality standards are met.

3. Responsibilities

Manufacturing Team: Responsible for identifying overfilled or underfilled capsules during the filling process, following the necessary steps to segregate them, and providing relevant details for further investigation and correction.
Quality Control (QC) Team: Responsible for verifying that the capsules meet the fill weight specifications and ensuring that all non-conforming capsules are segregated and properly documented.
Quality Assurance (QA) Team: Ensures that this SOP is adhered to and verifies that the necessary corrective actions are implemented in case of overfilled or underfilled capsules.
Capsule Manufacturing Supervisor: Oversees the capsule filling process and ensures the proper handling and documentation of overfilled or underfilled capsules, ensuring that the appropriate corrective actions are taken.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that overfilled or underfilled capsules are properly identified and handled according to this SOP. The QA Manager is responsible for ensuring compliance with this procedure and reviewing records for regulatory compliance.

5. Procedure

5.1 Identification of Overfilled or Underfilled Capsules

During the filling process, capsules may be overfilled or underfilled. Follow these steps to identify such capsules:

Visual Inspection
1. Conduct visual inspection of capsules during the filling process to identify any that appear too full (overfilled) or too empty (underfilled). Pay particular attention to size and symmetry.
Weight Inspection
1. Perform regular weight checks on a sample of capsules throughout the filling process. Use calibrated weighing scales to measure capsule weight and compare the results to the target weight specifications.
2. If the average weight is outside of the acceptable range (typically ±5% of the target weight), investigate the issue further.
Automated Inspection Systems
1. If an automated weight inspection system is available, use it to continuously monitor the fill weight of capsules during the production process. The system should flag any capsules that deviate from the specified weight range.

5.2 Segregation of Overfilled or Underfilled Capsules

Once overfilled or underfilled capsules are identified, follow these steps:

Segregation of Defective Capsules
1. Immediately remove any overfilled or underfilled capsules from the production line to prevent contamination with correctly filled capsules.
2. Place defective capsules in a designated container or area clearly marked as “Rejected.” Ensure the area is secure to avoid accidental contamination of non-defective capsules.
Identification and Labeling
1. Label the containers or storage areas containing rejected capsules with clear information, such as the batch number, defect type (overfilled or underfilled), and the number of capsules removed.

5.3 Investigation and Corrective Actions

After identifying and segregating defective capsules, follow these steps to investigate the cause and implement corrective actions:

Root Cause Analysis
1. Investigate the cause of overfilling or underfilling. Potential causes may include inconsistent fill material, equipment malfunction, or improper machine settings.
2. Perform a detailed investigation to identify whether the issue is isolated to a specific batch or if it represents a systematic problem in the filling process.
Corrective Actions
1. If the issue is equipment-related, schedule immediate maintenance and calibration of the filling machine to ensure that the fill material is dispensed accurately.
2. If the issue is related to material properties (e.g., inconsistent viscosity or moisture content), adjust the material formulation or handling procedures.
3. After corrective actions are taken, restart the filling process and perform additional checks to verify that the issue has been resolved.

5.4 Rework or Disposal of Defective Capsules

After identifying the cause and implementing corrective actions, the following steps should be followed for the defective capsules:

Rework
1. If the overfilled or underfilled capsules can be reworked (e.g., by adjusting the fill weight or resealing), follow the appropriate procedures for rework and documentation.
Disposal
1. If the capsules cannot be reworked, dispose of them in accordance with environmental and safety regulations. Ensure that all disposed capsules are documented and the disposal method is compliant with regulatory guidelines.

5.5 Documentation and Record-Keeping

Ensure proper documentation of all actions taken during the handling of overfilled or underfilled capsules:

Segregation and Investigation Records
1. Document all overfilled or underfilled capsules, including the number of defective capsules, the batch number, and the cause of the issue.
Corrective Action Records
1. Document any corrective actions taken, including the maintenance or calibration performed, material adjustments made, or any other actions taken to prevent recurrence.
Deviation Reports
1. Document any deviations from the specified fill weight, including the corrective actions taken, and the outcome of the rework or disposal process.

6. Abbreviations

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

7. Documents

Capsule Fill Weight Record (Annexure-1)
Deviation Report (Annexure-2)
Corrective Action Record (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: Capsule Fill Weight Record

Batch ID	Capsule Size	Target Fill Weight	Actual Fill Weight	Deviation	Operator Name	Production Date
Batch 001	Hard Gelatin	500 mg	505 mg	5% Overfill	John Doe	01/02/2025

Annexure-2: Deviation Report

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

Annexure-3: Corrective Action Record

Action ID	Action Taken	Responsible Person	Completion Date
CA-001	Adjusted machine calibration	John Smith	01/02/2025

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 fill weight limits	Standardization	QA Head