Standard Operating Procedure for Visual Inspection of Capsule Shells
| Department | Capsule Manufacturing |
|---|---|
| SOP No. | SOP/CM/181/2025 |
| Supersedes | SOP/CM/181/2022 |
| Page No. | Page 1 of 8 |
| 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 visually inspecting capsule shells to ensure that they meet the required quality standards. Visual inspection is a critical step to detect defects such as cracks, chips, incomplete sealing, and foreign contamination, ensuring that only acceptable products proceed to the next stage of production.
2. Scope
This SOP applies to the visual inspection of capsule shells during the manufacturing process. It covers the inspection criteria, procedures for identifying defects, and actions to be taken when defects are detected.
3. Responsibilities
- Quality Control (QC) Team: Responsible for performing the visual inspection of capsule shells, ensuring compliance with the acceptance criteria, and documenting the results. The QC team also ensures proper segregation of defective capsules.
- Quality Assurance (QA) Team: Responsible for reviewing and approving the visual inspection criteria and ensuring that the process meets GMP and regulatory standards. QA also handles the investigation of any deviations found during inspection.
- Production Team: Ensures that the capsules are provided for inspection and that any necessary corrective actions are taken in case of defects found during the inspection process.
- Supervisory Personnel: Responsible for training operators and inspectors on the proper visual inspection techniques and ensuring that the inspection process is carried out consistently.
4. Accountability
The QA Manager is accountable for ensuring that the visual inspection process is carried out in compliance with GMP and regulatory standards. The QC Supervisor is responsible for ensuring that the inspection is conducted accurately and that defective capsules are properly segregated. The Production Supervisor is accountable for ensuring the availability of capsules for inspection at the appropriate stage of production.
5. Procedure
5.1 Pre-Inspection Setup
Before initiating the visual inspection of capsule shells, ensure the following steps are completed:
-
Review Inspection Criteria
- Review the visual inspection criteria to ensure they align with product specifications. The criteria should include acceptable limits for size, color, shape, sealing, and any other relevant parameters. The criteria must be approved by the QA department.
-
Prepare Inspection Area
- Ensure that the inspection area is clean, well-lit, and free of distractions. The inspection should be carried out under controlled lighting conditions to detect defects accurately.
-
Calibrate Inspection Equipment
- If magnification or specialized lighting is used for the inspection, ensure that the equipment is calibrated and maintained in accordance with the manufacturer’s instructions. Document calibration details in the Equipment Calibration Log (Annexure 1).
5.2 Capsule Shell Inspection Process
Follow these steps for the visual inspection of capsule shells:
-
Visual Inspection
- Inspect each capsule shell individually for defects. Key parameters to inspect include:
- Integrity of the capsule shell (check for cracks, holes, or tears)
- Proper sealing of capsule halves
- Uniformity of shape and size
- Color consistency
- Presence of foreign material or contamination
- Inspect each capsule shell individually for defects. Key parameters to inspect include:
-
Inspection Methodology
- The inspection can be done manually or using automated visual inspection systems, depending on the scale of production. If manual inspection is performed, use a magnifying glass or microscope to identify small defects.
- Ensure that each capsule is turned and inspected from multiple angles to identify any hidden defects.
-
Defective Capsule Identification
- Any capsule that does not meet the defined quality criteria must be identified and segregated. Record the type of defect and the number of defective capsules.
- Defective capsules should be discarded or returned for rework, depending on the severity of the defect and the manufacturing process.
-
Documentation of Results
- Document all inspection results in the Visual Inspection Log (Annexure 2). Include the batch number, total number of capsules inspected, the number of defective capsules, and the type of defects identified.
5.3 Post-Inspection Activities
Once the inspection is completed, ensure the following activities are performed:
-
Review Inspection Results
- The QA Manager reviews the inspection results to ensure compliance with the defined quality criteria. If a significant number of defects are found, initiate an investigation to identify the root cause.
-
Corrective Actions
- If any defects are identified, the Production Supervisor must implement corrective actions to address the issue. This could include equipment maintenance, adjustment of process parameters, or review of raw materials.
-
Training and Feedback
- If defects are due to human error, additional training on visual inspection techniques may be necessary. Provide feedback to the inspectors to prevent future occurrences.
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Archiving Inspection Records
- Archive all inspection documentation, including the inspection logs, defect records, and corrective action reports, in accordance with regulatory retention requirements.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- QC: Quality Control
- RH: Relative Humidity
7. Documents
- Annexure 1: Equipment Calibration Log
- Annexure 2: Visual Inspection Log
- Annexure 3: Defective Capsule Report
8. References
- FDA Guidance on Pharmaceutical Packaging and Inspection
- Good Manufacturing Practice (GMP) Guidelines
- USP <711> – Dissolution Testing
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure 1: Equipment Calibration Log
| Equipment ID | Calibration Date | Operator | Calibration Details | Next Calibration Due |
|---|---|---|---|---|
| Capsule Shell Visual Inspector 110 | 01/02/2025 | John Doe | Calibration of magnification and lighting conditions | 01/02/2026 |
Annexure 2: Visual Inspection Log
| Batch ID | Inspection Date | Capsules Inspected | Defective Capsules | Defect Type | Corrective Action Taken |
|---|---|---|---|---|---|
| Batch 001 | 02/02/2025 | 1000 | 5 | Cracked Shell | Adjusted sealing parameters |
Annexure 3: Defective Capsule Report
| Batch ID | Defect Type | Quantity Defective | Remarks |
|---|---|---|---|
| Batch 001 | Cracked Shell | 5 | Defects occurred during sealing stage |
12. Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial version of SOP | Creation of SOP for visual inspection of capsule shells | QA Head |
| 01/02/2025 | 2.0 | Updated defect types and corrective actions | Improved inspection procedures and defect handling | QA Head |