Standard Operating Procedure for Capsule Batch Number Allocation and Tracking

Department	Capsule Manufacturing
SOP No.	SOP/CM/069/2025
Supersedes	SOP/CM/069/2022
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 procedure for allocating and tracking batch numbers for capsules produced during manufacturing. A systematic approach to batch number allocation ensures traceability, compliance with regulatory requirements, and effective quality control throughout the production process.

2. Scope

This SOP applies to all capsule production batches within the manufacturing facility. It covers the procedures for assigning batch numbers, documenting batch information, and maintaining records for tracking and traceability purposes.

3. Responsibilities

• Manufacturing Team: Responsible for ensuring that the correct batch numbers are assigned to the capsules during production and that batch records are accurately maintained.
• Quality Control (QC) Team: Responsible for verifying the batch number allocation and ensuring that proper documentation is maintained to facilitate traceability and auditing processes.
• Quality Assurance (QA) Team: Ensures compliance with the SOP, reviews batch records, and oversees the traceability system to ensure it meets regulatory requirements.
• IT and Records Management Team: Responsible for maintaining electronic systems and records to ensure accurate batch tracking and retrieval.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that batch numbers are allocated correctly and that proper tracking procedures are followed. The QA Manager is responsible for reviewing batch records and ensuring compliance with regulatory standards.

5. Procedure

5.1 Allocation of Batch Numbers

The following steps should be followed for allocating batch numbers during capsule production:

1. Batch Number Format
   1. Define the batch number format based on company standards. A typical format includes information such as the product code, production date, and a unique batch number (e.g., PROD-20250201-001).
   2. Ensure that the format is consistent across all batches to allow for easy identification and tracking.
2. Assignment of Batch Number
   1. Assign a unique batch number to each production batch. The batch number should be linked to the production record, raw material lot numbers, and other relevant manufacturing details.
   2. Batch numbers should be assigned in a sequential manner to prevent duplication and ensure traceability.
3. Record the Batch Information
   1. Record the batch number, product details, date of manufacture, and operator information in the batch production record (BPR). This will provide a comprehensive log of each batch produced, facilitating traceability.

5.2 Tracking of Batch Numbers

Once the batch number is assigned, ensure that the batch is tracked throughout the production and distribution process:

1. Documentation of Batch Details
   1. Ensure that all batch details, including the batch number, product specifications, raw material lot numbers, and equipment used, are documented in the batch production record and related documentation.
2. Batch Number on Packaging
   1. Ensure that the batch number is printed on the packaging of the capsules, including primary, secondary, and tertiary packaging, to ensure full traceability during distribution.
3. Real-Time Tracking System
   1. If available, use a computerized system to track batch numbers in real time. The system should be updated throughout the production process to provide immediate access to batch information for QC, QA, and regulatory purposes.
4. Inventory and Distribution Tracking
   1. Track each batch from production through to distribution, ensuring that the batch number is recorded at each stage of the supply chain. This includes storage, shipping, and delivery to customers or distributors.

5.3 Batch Number Traceability and Retrieval

Ensure that batch numbers can be traced and retrieved quickly for quality control, auditing, or regulatory inspections:

1. Batch Record Retrieval
   1. Maintain an organized system for storing batch records and related documents. Ensure that batch numbers are easily searchable and that records can be retrieved promptly upon request.
2. Audit Trail
   1. Maintain an audit trail for each batch, documenting any deviations, corrective actions, or changes made during the production process. This ensures transparency and traceability in case of any issues.
3. Regulatory Compliance
   1. Ensure that the batch tracking system complies with regulatory requirements, including FDA, EMA, or other relevant authorities, by providing access to batch records when requested.

5.4 Batch Number Reconciliation

To ensure accuracy in batch tracking, perform regular batch number reconciliation:

1. Reconciliation After Production
   1. Once a batch is completed, perform a reconciliation process to ensure that all materials used and capsules produced are accounted for under the correct batch number.
2. Reconciliation with Inventory Records
   1. Reconcile batch production records with inventory and distribution records to ensure that all capsules are properly accounted for and no discrepancies exist between the number of capsules produced and the number recorded in the system.

5.5 Batch Number Modifications

If any changes or modifications to the batch number are required, follow these procedures:

1. Documentation of Changes
   1. Any changes to batch numbers should be documented in the batch record, including the reason for the change and who authorized it. Ensure that all changes are made in compliance with GMP and regulatory standards.
2. Approval for Changes
   1. Changes to batch numbers should only be made with the approval of the QA Manager or another authorized individual to ensure traceability and prevent confusion or errors in batch tracking.

5.6 Documentation and Record-Keeping

Ensure proper documentation of all batch numbers and related activities:

1. Batch Production Records
   1. Maintain detailed batch production records for each batch produced, including batch number, raw materials, production conditions, and any deviations or issues encountered.
2. Batch Tracking Log
   1. Maintain a batch tracking log that documents all batch numbers, the status of each batch, and any actions taken throughout the production and distribution process.
3. Retention of Records
   1. Ensure that all batch production records and tracking logs are retained for the required period, in compliance with regulatory requirements, to allow for audits or inspections.

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 (Annexure-1)
2. Batch Tracking Log (Annexure-2)
3. Batch Number Allocation Form (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: Batch Production Record

Batch ID	Capsule Size	Production Date	Batch Number	Operator Name
Batch 001	Hard Gelatin	01/02/2025	PROD-20250201-001	John Doe

Annexure-2: Batch Tracking Log

Batch ID	Capsule Size	Status	Action Taken	Remarks
Batch 001	Hard Gelatin	Completed	Shipped to Distributor	No issues

Annexure-3: Batch Number Allocation Form

Batch Number	Product Name	Assigned Date	Allocated By
PROD-20250201-001	Hard Gelatin Capsules	01/02/2025	John Doe

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 batch allocation process	Standardization	QA Head