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:

1. Determine the Lot Number Format
   1. 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).
   2. The format should be consistent across all batches to ensure clarity and traceability.
2. Assign a Lot Number for Each Production Batch
   1. Before the start of production, the production supervisor should assign a unique lot number to the batch based on the established format.
   2. 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:

1. Prepare Labeling Materials
   1. 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.
   2. Verify that the labeling equipment is functioning properly and that the labels are clear and legible.
2. Apply the Lot Numbers to Capsules
   1. Once the capsules are ready for packaging, apply the lot number labels to each batch of capsules as they move through the production line.
   2. Ensure that the lot number is clearly visible on the capsule packaging or container, in compliance with regulatory and company standards.
3. Verify Correct Application of Lot Numbers
   1. The QC team should perform regular checks during production to ensure that the lot numbers are being applied correctly.
   2. 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:

1. Record Lot Numbers
   1. 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.
   2. Ensure that the lot numbers are linked to the production and packaging records for traceability purposes.
2. Maintain Records for Future Reference
   1. Maintain an electronic or physical log of all assigned lot numbers for auditing and inventory management purposes.
   2. 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:

1. Document the Deviation
   1. Any deviation or error in lot numbering (e.g., duplicate lot number, missing number) must be documented in the deviation log.
   2. Provide details of the deviation, such as the cause and corrective actions taken.
2. Investigate the Cause of the Deviation
   1. Investigate the cause of the lot number discrepancy, such as labeling equipment malfunction, human error, or system errors.
   2. Determine whether the discrepancy impacts the batch and whether corrective actions need to be taken to address it.
3. Implement Corrective Actions
   1. Corrective actions should be taken immediately to resolve the issue and ensure proper lot numbering in future batches.
   2. 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:

1. Final QA Review
   1. QA personnel should verify the lot number labels to ensure accuracy and compliance with regulatory requirements.
   2. The QA team should ensure that all records are properly completed and that the lot numbers are correctly documented in the batch records.
2. Production Approval
   1. 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:

1. Maintain Documentation
   1. Ensure that all documents related to lot numbers, including Batch Production Records and deviation reports, are stored for the required retention period.
2. Labeling System Tracking
   1. 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

1. Batch Production Record (BPR) (Annexure-1)
2. Deviation Log (Annexure-2)
3. 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)

You said:
Continue
ChatGPT said:
html
Copy

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