Standard Operating Procedure for Labeling Capsules with Lot Numbers
Department | Capsule Manufacturing |
---|---|
SOP No. | SOP/CM/090/2025 |
Supersedes | SOP/CM/090/2022 |
Page No. | Page 1 of 5 |
Issue Date | 01/02/2025 |
Effective Date | 05/02/2025 |
Review Date | 01/02/2026 |
1. Purpose
The purpose of this SOP is to establish a standardized procedure for labeling capsules with lot numbers. Proper lot numbering is crucial for traceability, inventory management, and regulatory compliance, ensuring that capsules can be identified and traced throughout the manufacturing and distribution process.
2. Scope
This SOP applies to all capsules manufactured in the facility, including both hard and soft gelatin capsules. It covers the process of assigning, labeling, and recording lot numbers on capsules before they are packaged and shipped.
3. Responsibilities
- Production Operators: Responsible for applying the lot number labels to capsules during production, ensuring that the correct lot number is used for each batch of capsules.
- Quality Control (QC) Team: Responsible for verifying that the lot numbers are applied correctly and that they are consistent with batch records.
- Quality Assurance (QA) Team: Ensures that the labeling process complies with GMP standards and maintains traceability for all capsules produced.
- Production Supervisor: Oversees the labeling process and ensures that operators are following the SOP and correctly labeling the capsules with the appropriate lot number.
4. Accountability
The Capsule Manufacturing Supervisor is accountable for ensuring that the correct lot numbers are applied to capsules during production. The QA Manager is responsible for reviewing the labeling process and ensuring that it meets regulatory requirements.
5. Procedure
5.1 Assigning Lot Numbers
The process of assigning lot numbers to capsules should be conducted as follows:
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Determine the Lot Number Format
- Lot numbers should be assigned using a predetermined format that includes the production date, product code, and a sequential batch number (e.g., 2025-001-01).
- The format should be consistent across all batches to ensure clarity and traceability.
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Assign a Lot Number for Each Production Batch
- Before the start of production, the production supervisor should assign a unique lot number to the batch based on the established format.
- The lot number should be recorded in the Batch Production Record (BPR) and any other relevant documentation.
5.2 Labeling Capsules with Lot Numbers
Once the lot number has been assigned, follow these steps to label the capsules:
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Prepare Labeling Materials
- Ensure that the appropriate labels with the lot numbers are available for use during production. These labels should be pre-printed or generated using a labeling machine with the correct lot number information.
- Verify that the labeling equipment is functioning properly and that the labels are clear and legible.
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Apply the Lot Numbers to Capsules
- Once the capsules are ready for packaging, apply the lot number labels to each batch of capsules as they move through the production line.
- Ensure that the lot number is clearly visible on the capsule packaging or container, in compliance with regulatory and company standards.
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Verify Correct Application of Lot Numbers
- The QC team should perform regular checks during production to ensure that the lot numbers are being applied correctly.
- If any discrepancies are found (e.g., incorrect lot number or label misplacement), stop the production line immediately and correct the issue before resuming the process.
5.3 Documenting the Lot Numbering Process
Once the lot numbers are applied, ensure proper documentation:
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Record Lot Numbers
- Record the assigned lot number in the Batch Production Record (BPR), along with other relevant production details, such as batch size, product code, and manufacturing date.
- Ensure that the lot numbers are linked to the production and packaging records for traceability purposes.
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Maintain Records for Future Reference
- Maintain an electronic or physical log of all assigned lot numbers for auditing and inventory management purposes.
- Ensure that lot numbers are easily retrievable for tracking capsules in the supply chain, especially in case of recalls or quality investigations.
5.4 Handling Lot Number Discrepancies
If any discrepancies in lot numbering are detected, the following actions should be taken:
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Document the Deviation
- Any deviation or error in lot numbering (e.g., duplicate lot number, missing number) must be documented in the deviation log.
- Provide details of the deviation, such as the cause and corrective actions taken.
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Investigate the Cause of the Deviation
- Investigate the cause of the lot number discrepancy, such as labeling equipment malfunction, human error, or system errors.
- Determine whether the discrepancy impacts the batch and whether corrective actions need to be taken to address it.
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Implement Corrective Actions
- Corrective actions should be taken immediately to resolve the issue and ensure proper lot numbering in future batches.
- Update any relevant documentation to reflect the correct lot numbers and ensure that all affected batches are properly labeled and tracked.
5.5 Approving Lot Numbers
After the labeling process, ensure that the following steps are taken before moving forward with production:
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Final QA Review
- QA personnel should verify the lot number labels to ensure accuracy and compliance with regulatory requirements.
- The QA team should ensure that all records are properly completed and that the lot numbers are correctly documented in the batch records.
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Production Approval
- Once QA approves the lot numbers and labeling process, production can proceed with the next steps, including packaging and distribution.
5.6 Record Retention and Traceability
To maintain traceability, the following steps should be followed:
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Maintain Documentation
- Ensure that all documents related to lot numbers, including Batch Production Records and deviation reports, are stored for the required retention period.
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Labeling System Tracking
- Ensure that the labeling system is capable of tracking all lot numbers for efficient retrieval in case of audits, recalls, or quality investigations.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- BPR: Batch Production Record
7. Documents
- Batch Production Record (BPR) (Annexure-1)
- Deviation Log (Annexure-2)
- Labeling 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
- Good Manufacturing Practice (GMP) Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
Prepared By | Checked By | Approved By | |
---|---|---|---|
Signature | |||
Date | |||
Name | |||
Designation | |||
Department |
11. Annexures
Annexure-1: Batch Production Record (BPR)
Batch ID | Lot Number | Production Date | Operator Name | Approval Status |
---|---|---|---|---|
Batch 001 | 2025-001-01 | 01/02/2025 | John Doe | Approved |
Annexure-2: Deviation Log
Deviation ID | Description | Corrective Action Taken | Operator Name | Approval Status |
---|---|---|---|---|
DEV-001 | Incorrect lot number applied | Corrected lot number and relabeled | Jane Smith | Approved |
Annexure-3: Labeling Log
Batch ID | Lot Number | Labeling Date | Operator Name | Approval Status |
---|---|---|---|---|
Batch 001 | 2025-001-01 | 01/02/2025 | John Doe | Approved |
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 lot numbering and labeling process | Standardization | QA Head |