Standard Operating Procedure for Online Capsule Inspection During Filling

Department	Capsule Manufacturing
SOP No.	SOP/CM/060/2025
Supersedes	SOP/CM/060/2022
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 procedures for conducting online inspection of capsules during the filling process. This ensures that capsules are filled properly and meet the required specifications for size, fill weight, and uniformity before they are sealed and processed further.

2. Scope

This SOP applies to all capsule filling operations where online inspection is required. It covers the inspection methods, equipment used, and frequency of checks to ensure the capsules meet quality standards.

3. Responsibilities

• Manufacturing Team: Responsible for operating the capsule filling and inspection equipment, ensuring that the inspection is carried out as per the SOP, and addressing any detected issues immediately.
• Quality Control (QC) Team: Responsible for verifying the integrity of the inspection process and ensuring the capsules meet the required specifications during production.
• Quality Assurance (QA) Team: Ensures that the SOP is followed during the filling process and that the documentation is complete and compliant with GMP and regulatory requirements.
• Maintenance Team: Responsible for ensuring that the capsule filling and inspection equipment is properly maintained and calibrated to prevent inspection errors during production.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the online inspection process is followed according to the SOP. The QA Manager is responsible for reviewing inspection data and ensuring compliance with regulatory standards.

5. Procedure

5.1 Pre-Inspection Setup

Before starting the filling and inspection process, ensure the following steps are completed:

1. Equipment Inspection
   1. Ensure that the capsule filling and inspection equipment is properly calibrated and cleaned before starting the process. Check that all machine parts are in good working condition and free of any debris or contaminants.
   2. Ensure that the inspection system is set up to monitor fill weight, capsule size, and uniformity. If using an automated vision system, verify that it is correctly calibrated.
2. Material and Capsule Preparation
   1. Ensure that the capsule filling material (powder, liquid, or gel) is properly prepared and within the required specifications.
   2. Check that the capsule shells are in proper condition and ready for filling.
3. Documentation
   1. Document the batch details, machine settings, and inspection parameters before starting the filling process. This should include information on capsule size, fill weight, and the number of capsules to be inspected.

5.2 Online Capsule Inspection Process

Once the pre-inspection setup is completed, begin the inspection process as follows:

1. Continuous Monitoring
   1. As capsules are filled, continuously monitor the capsules for size, fill weight, and uniformity. Use the automated inspection system (if available) or manual visual inspection to detect any abnormalities.
   2. Ensure that capsules are inspected at regular intervals during the filling process to detect any issues early on. The frequency of checks will depend on the machine speed and batch size.
2. Weight Inspection
   1. Measure the weight of a representative sample of capsules from each batch to ensure that they meet the specified fill weight. Capsules that are underweight or overweight should be removed from the production line and replaced.
   2. If weight variation exceeds the acceptable limits, stop the machine and investigate the cause (e.g., inconsistent filling, material issues).
3. Visual Inspection
   1. Perform a visual inspection of the capsules to check for defects such as cracks, incomplete filling, or capsule shell damage. Any defective capsules should be segregated for further investigation and rejected from the production line.
4. Online Vision System (if available)
   1. For automated systems, ensure the vision system is correctly identifying defective capsules. The system should flag any capsules with fill defects, improper size, or damaged shells. Review flagged capsules for rejection and documentation.

5.3 Post-Inspection Review

After completing the inspection, perform the following checks:

1. Inspection Data Review
   1. Review the data from the inspection process, including capsule weight, size, and visual inspection results. Ensure that all capsules meet the established quality standards.
2. Deviation Documentation
   1. If any deviations from the specified limits are found, document the deviations and take corrective actions. This could include adjusting the filling machine, changing the capsule shells, or improving the inspection process.
3. Capsule Segregation
   1. Segregate all capsules that do not meet the quality specifications. These capsules should be either reworked (if applicable) or discarded according to the deviation report.

5.4 Equipment Maintenance and Cleaning

After completing the inspection process, follow these steps for cleaning and maintaining the equipment:

1. Cleaning the Inspection System
   1. Turn off the machine and clean all components, including the capsule feed system, inspection system, and any associated machinery. Use appropriate cleaning agents to remove any residues from capsules or materials.
2. Maintenance of Inspection Equipment
   1. Perform routine maintenance on the capsule inspection equipment, including calibration checks and visual inspections of components such as cameras or sensors in automated systems.

5.5 Documentation and Record-Keeping

Document all inspection activities thoroughly for traceability and compliance:

1. Inspection Records
   1. Document all capsule inspection details, including batch number, machine settings, inspection results, and any corrective actions taken.
2. Quality Control Records
   1. Ensure that QC records include details of any defects detected during the inspection, including capsule weight, size, and appearance.
3. Deviation Reports
   1. Document any deviations from the quality standards, including the cause of the issue, corrective actions taken, and verification of the effectiveness of the correction.

6. Abbreviations

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

7. Documents

1. Capsule Inspection Record (Annexure-1)
2. Quality Control Test Report (Annexure-2)
3. Deviation Report (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 Inspection Record

Batch ID	Capsule Size	Filling Machine ID	Weight Inspection Result	Visual Inspection Result	Operator Name	Production Date
Batch 001	Hard Gelatin	Machine 15	Pass	Pass	John Doe	01/02/2025

Annexure-2: Quality Control Test Report

Test Type	Result	Specification	Remarks
Weight Uniformity	Pass	95-105 mg	Meets standards

Annexure-3: Deviation Report

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

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 inspection steps and frequency	Standardization	QA Head