Standard Operating Procedure for Traceability of Dispensed Materials

Department	Capsule Manufacturing
SOP No.	SOP/CM/013/2025
Supersedes	SOP/CM/013/2022
Page No.	Page 1 of 6
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

To define the procedures for ensuring traceability of materials dispensed during the capsule manufacturing process, ensuring that all materials are properly accounted for and documented for regulatory and quality assurance purposes.

2. Scope

This SOP applies to all dispensing operations in capsule manufacturing, focusing on maintaining the traceability of materials from receipt to dispensing, including active pharmaceutical ingredients (APIs) and excipients.

3. Responsibilities

• Manufacturing Personnel: Responsible for documenting the dispensed materials in the appropriate logs and ensuring the traceability of materials throughout the dispensing process.
• Quality Control (QC) Team: Ensures the accuracy and completeness of records related to the traceability of dispensed materials.
• Quality Assurance (QA) Team: Oversees compliance with traceability requirements and ensures that all documentation is in place and auditable.
• Warehouse Personnel: Responsible for ensuring that materials are received and stored properly, and that relevant records are provided for traceability.

4. Accountability

The Manufacturing Supervisor is accountable for ensuring traceability throughout the dispensing process. The QA Manager is responsible for ensuring that all materials are traceable, properly documented, and compliant with regulations.

5. Procedure

5.1 Material Identification

Before dispensing, ensure all materials are properly identified to guarantee traceability:

1. Labeling of Materials
   1. Ensure that all materials are properly labeled with their name, batch number, expiry date, and supplier details upon receipt.
   2. Check the labels against the work order and batch record to ensure that the correct material is selected for dispensing.
2. Verification of Materials
   1. Before dispensing, verify the identity of each material by checking the label, Certificate of Analysis (CoA), and other documentation to ensure the material matches the work order.
   2. Ensure that materials are not dispensed if there are discrepancies in the labeling or documentation. Document any discrepancies in the Discrepancy Report (Annexure-1).

5.2 Documenting Dispensed Materials

Ensure that all dispensing activities are documented for traceability:

1. Material Dispensing Log
   1. Document each dispensed material in the Material Dispensing Log (Annexure-2), including the material name, batch number, quantity dispensed, work order reference, and the personnel involved.
   2. Record any deviations from the planned dispensing quantities or material substitutions in the log, along with the reasons for such deviations.
2. Batch Manufacturing Record (BMR)
   1. Ensure that dispensing details are recorded in the BMR, including the specific materials dispensed for each batch, the batch number, the quantity dispensed, and the responsible personnel.
   2. Ensure that the BMR is signed by the dispensing operator and verified by the QA team to confirm accuracy and compliance.
3. Traceability Tags and Barcodes
   1. Utilize barcode labels or RFID tags for each material, if applicable, to enhance traceability during dispensing. Scan these tags into the system to automatically log dispensing data into the batch record.
   2. Ensure that the barcode scanning system is functional and properly linked to the manufacturing and quality control databases for easy tracking.

5.3 Verification and Cross-Checking

Verification of traceability records is critical to maintaining integrity:

1. QA Verification
   1. The QA team should regularly verify the completeness and accuracy of the Material Dispensing Log and BMR entries.
   2. Ensure that all fields are filled out accurately, including material batch numbers, quantities dispensed, and personnel signatures.
2. Cross-Check With Other Records
   1. Cross-check the dispensing records with the inventory records to ensure that dispensed quantities are accurately reflected in stock levels and that there are no discrepancies.
   2. Ensure that the materials dispensed match the work order and the batch record to confirm traceability throughout the manufacturing process.

5.4 Handling Non-Conforming Materials

In the case of non-conforming materials, the following steps should be followed:

1. Quarantine Non-Conforming Materials
   1. If a material is found to be non-conforming (e.g., wrong batch number, incorrect material), immediately quarantine it to prevent further use in dispensing.
   2. Label the material as “Quarantined” and restrict access to it until an investigation is completed.
2. Document the Deviation
   1. Document the deviation and initiate an investigation in the Discrepancy Report (Annexure-1) to determine the root cause.
   2. Once the deviation is resolved, update the Material Dispensing Log and BMR accordingly, documenting the corrective actions taken.

5.5 Retrieving Historical Data

To maintain traceability, ensure that historical data can be retrieved for audits or inspections:

1. Record Retention
   1. Ensure that the Material Dispensing Log, BMR, and all other related documentation are retained for the required duration as per the company’s record retention policy and regulatory requirements.
   2. Store these records securely, ensuring they are readily accessible for audits or inspections.
2. Traceability Report
   1. Generate a traceability report from the system whenever needed, showing the history of all dispensed materials, including batch numbers, quantities, and personnel details.
   2. Ensure that the report is complete and accurate, covering all necessary data for traceability purposes.

6. Abbreviations

• SOP: Standard Operating Procedure
• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• QC: Quality Control
• API: Active Pharmaceutical Ingredient
• PO: Purchase Order

7. Documents

1. Material Dispensing Log (Annexure-2)
2. Discrepancy Report (Annexure-1)
3. Batch Manufacturing Record (BMR) (Annexure-3)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• EU GMP Guidelines Part I – Basic Requirements for Medicinal Products

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Discrepancy Report

Date	Material Name	Batch Number	Issue Description	Corrective Action
03/02/2025	Excipient-456	Batch 12345	Batch number mismatch	Corrected and updated records

Annexure-2: Material Dispensing Log

Date	Material Name	Batch Number	Quantity Dispensed	Dispensed By
03/02/2025	API-123	Batch 56789	500 g	John Doe

Annexure-3: Batch Manufacturing Record (BMR)

Date	Material Name	Batch Number	Quantity Dispensed	Dispensed By
03/02/2025	Excipient-456	Batch 12345	500 g	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 traceability procedures	Standardization	QA Head