Standard Operating Procedure for Batch Coding and Tracking during Cream Manufacturing
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/052/2025 |
| Supersedes | SOP/CRM/052/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 12/11/2025 |
| Effective Date | 17/11/2025 |
| Review Date | 12/11/2026 |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish the process for batch coding and tracking during the manufacturing of cream products. Batch coding is a critical part of traceability in the manufacturing process, enabling the identification of each batch of product for quality control, inventory management, and regulatory compliance. This SOP ensures that all batch codes are correctly assigned, tracked, and documented during the production process.
2. Scope
This SOP applies to all cream batches produced in the Creams Department. It covers the procedures for assigning, documenting, and tracking batch codes from the start of production to the final packaging stage.
3. Responsibilities
- Production Team: Responsible for assigning batch codes to each cream batch during the production process and ensuring that batch numbers are applied to all relevant documents and products.
- Quality Control (QC): Responsible for verifying that batch codes are correctly applied to all relevant materials, including raw materials, in-process products, and final products, and ensuring compliance with regulatory requirements for batch traceability.
- Quality Assurance (QA): Ensures that batch coding and tracking processes are followed in compliance with this SOP and that batch records are complete and accurate before approval for packaging.
- Warehouse/Inventory Team: Responsible for maintaining proper records of batch numbers during storage and ensuring that batch codes are correctly logged in inventory management systems.
4. Accountability
The Head of Creams Manufacturing is responsible for ensuring that batch coding and tracking procedures are followed at all stages of production. The QA Manager is accountable for verifying compliance with batch coding processes and ensuring that the batch records are complete and accurate.
5. Procedure
5.1 Assignment of Batch Code
- Before starting any production run, the Production Team must assign a unique batch code to the new batch, following the format specified in the MFR (e.g., CRM-YYYY-MM-BatchNumber). This batch code will be used to identify the batch throughout the production and packaging process.
- Ensure that the batch code is documented on all relevant documents, including the batch record, raw material log, and production sheets.
- The batch code must be applied to the product at the first stage of manufacturing, such as during mixing or emulsification, and must be referenced throughout the subsequent stages.
5.2 Documentation of Batch Code
- The batch code should be documented on all relevant production records, including the batch record, raw material receipts, in-process sampling logs, and final quality control testing reports.
- Ensure that all documentation includes the batch code, production date, operator details, and any other relevant information as per the MFR.
- The batch code must be clearly visible on packaging materials, including labels, cartons, and containers, to facilitate traceability.
5.3 Tracking of Batch Code
- Once the batch code is assigned and documented, it should be tracked throughout the entire manufacturing process, including mixing, filling, and packaging.
- The batch code should be recorded in the inventory management system, along with information about the raw materials used, production date, and batch quantity.
- Periodically review the batch code tracking logs to ensure that all information is complete and accurate. Any discrepancies in the tracking logs should be immediately investigated and corrected.
5.4 Final Packaging and Labeling
- Before packaging, ensure that the batch code is applied to all product packaging, including labels, cartons, and shipping materials. The batch code should be printed on each container of cream for easy identification.
- Verify that the batch code appears clearly and legibly on all packaging materials to ensure proper traceability and compliance with regulatory requirements.
- Ensure that batch codes are also recorded on the packaging batch record and in the inventory system before the product is released for distribution.
5.5 Batch Traceability
- In case of any product recall or quality issues, the batch code will be used to trace the affected product back to the specific batch. Ensure that all records are complete and up to date to facilitate batch traceability.
- Maintain records of all batch codes and related production information for a minimum of five years or as required by regulatory authorities.
- If a batch recall is initiated, the batch code will be used to identify all affected products, and affected inventory should be immediately segregated and quarantined.
5.6 Documentation and Reporting
- Document the batch coding and tracking process in the batch record, including any deviations, issues, or corrective actions taken during the process.
- The batch record should include the assigned batch code, raw material details, in-process samples, and final QC test results.
- Ensure that the completed batch record is reviewed and approved by QA before the product is released for packaging or shipment.
5.7 Final Approval and Distribution
- Once the batch code has been applied and the batch record is completed, the cream batch is ready for distribution. Ensure that the batch code is included in all documentation related to the shipment, including the shipping label and certificate of analysis.
- Final approval for distribution is granted once all batch code documentation has been verified and approved by QA.
6. Abbreviations
- QC: Quality Control
- QA: Quality Assurance
- GMP: Good Manufacturing Practices
- API: Active Pharmaceutical Ingredient
- MFR: Master Formula Record
7. Documents
- Batch Code Log (Annexure-1)
- Batch Record (Annexure-2)
- Inventory Tracking Log (Annexure-3)
8. References
- Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
- International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- FDA Guidelines for Cosmetics 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 Code Log
| Batch Number | Production Date | Assigned Batch Code | Operator |
|---|---|---|---|
| 12345 | 07/11/2025 | CRM-2025-11-12345 | John Doe |
Annexure-2: Batch Record
| Batch Number | Process Step | Time | Operator |
|---|---|---|---|
| 12345 | Batch Coding | 08:00 AM | Jane Smith |
Annexure-3: Inventory Tracking Log
| Batch Number | Storage Location | Quantity | Batch Code Applied |
|---|---|---|---|
| 12345 | Warehouse A | 1000 units | CRM-2025-11-12345 |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/03/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/03/2025 | 2.0 | Format Revision and Updates | Standardization of Document | QA Head |