Standard Operating Procedure for Material Identification and Labeling in Cream Manufacturing

Department	Creams
SOP No.	SOP/CRM/001/2025
Supersedes	SOP/CRM/001/2022
Page No.	Page 1 of 8
Issue Date	01/03/2025
Effective Date	05/03/2025
Review Date	01/03/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to ensure the accurate identification and proper labeling of materials used in the cream manufacturing process. This ensures that all materials are traceable, preventing mix-ups and ensuring compliance with regulatory and quality standards.

2. Scope

This SOP applies to all materials involved in cream manufacturing within the Creams Department. It covers processes such as the identification of raw materials, labeling protocols, and the management of materials throughout the production cycle.

3. Responsibilities

• Warehouse Personnel: Responsible for ensuring that all materials are correctly identified and labeled upon receipt.
• Production Team: Ensures proper labeling and identification of materials during formulation and processing.
• Quality Control (QC): Verifies that materials are appropriately labeled and stored according to regulatory guidelines.
• Quality Assurance (QA): Oversees the implementation of the SOP and performs audits to ensure compliance.

4. Accountability

The Head of Creams Manufacturing is accountable for ensuring that this SOP is followed during the cream manufacturing process. Compliance with the labeling and identification procedures is ultimately the responsibility of the Quality Assurance (QA) Manager.

5. Procedure

5.1 Material Receipt and Initial Identification

1. Upon receipt of raw materials, Warehouse Personnel must ensure each material is identified with the corresponding batch/lot number, supplier details, and material specifications. The materials should be visually inspected for any obvious signs of damage, such as tears in packaging or leaks. All materials must be verified against the Purchase Order (PO) to ensure the correct items have been delivered.
2. After verifying the materials against the PO, the batch/lot numbers and other relevant information should be logged into the Material Identification Log. Each material should also be assigned a unique identification number that corresponds to the internal material tracking system.
3. A quick check of the storage requirements for each material should be performed to ensure that the material is not exposed to conditions that might compromise its integrity. For example, materials requiring refrigeration should immediately be placed in temperature-controlled environments upon receipt.

5.2 Labeling of Materials

1. Every material must be labeled according to the established company standards. The label should include the material name, batch number, manufacturer or supplier details, the date of receipt, the manufacturing date (if applicable), and the expiry date (if applicable). Additionally, storage instructions and handling precautions must be included on the label to ensure proper storage and safe handling by personnel.
2. Labels should be printed clearly with legible text, using permanent ink or waterproof materials to ensure that the label remains intact during storage and usage. Labels should be applied securely to each container. If the material is stored in bulk or a large container, an additional label should be placed on the outside of the storage box or container to ensure proper identification.
3. Ensure that any secondary labels, such as hazardous material warnings or special storage instructions, are properly displayed and visible. All labels should be checked for accuracy before final use.

5.3 Verification of Labels

1. Before using any material in the manufacturing process, production team members must verify that the labels correspond to the materials they are using. This includes confirming the material name, batch number, storage instructions, and expiration dates. The label verification should be completed before moving materials to the production area.
2. The QC team will periodically audit the labeling system and verify the accuracy of labels against the material specifications. They should perform spot checks during batch production to ensure ongoing compliance with labeling protocols. If discrepancies are found, materials should be isolated and the issue should be reported to QA for further investigation.

5.4 Documentation of Materials

1. A Material Identification Log must be maintained at all times, recording key information such as the material name, batch number, supplier, receipt date, storage location, and any other relevant details. The log must be kept up to date and available for review by QC and QA personnel.
2. The QA team should review the Material Identification Log at regular intervals to ensure that all materials are being tracked accurately. Any discrepancies or missing entries should be addressed immediately to maintain proper traceability of all materials used in the manufacturing process.
3. In addition to the Material Identification Log, all material labels must be stored as part of the documentation package for each production batch. This ensures that if a material issue arises later in the process, there is a full record of the labeling and identification steps.

5.5 Storage and Access

1. Materials should be stored in designated, clearly marked areas according to their classification. Each storage area must be secured to prevent unauthorized access and to maintain the integrity of the materials. For example, hazardous materials should be stored in appropriate containers in a designated area with restricted access.
2. The warehouse team must regularly check materials in storage to ensure they are properly labeled and stored according to their specific requirements. Regular stock rotation (First In, First Out – FIFO) should be followed to ensure that materials with the shortest shelf life are used first.
3. Access to materials should be limited to authorized personnel. Personnel handling materials must be trained in material identification and labeling procedures to ensure that the SOP is followed correctly at all times.

5.6 Final Review and Compliance Check

1. Before any material is used in the manufacturing process, a final review must be conducted by the QC team to ensure that the materials are correctly labeled and identified according to the SOP. This includes verifying the material name, batch number, supplier details, and expiration date.
2. If any discrepancies are found during the final review, the material must be isolated and a corrective action plan must be implemented. The QA team must be notified of any labeling or identification issues, and an investigation must be conducted to determine the root cause.
3. Once the materials are verified, they can be released for use in the manufacturing process. A Material Release Form should be completed and signed by the QA team, and the materials should be moved to the appropriate production area.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• PO: Purchase Order
• APIs: Active Pharmaceutical Ingredients

7. Documents

1. Material Identification Log (Annexure-1)
2. Labeling Verification Form (Annexure-2)

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• Internal SOP for Labeling and Documentation Compliance

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Material Identification Log

Material Name	Batch Number	Supplier	Receipt Date	Storage Location
Active Ingredient X	12345	ABC Suppliers	01/03/2025	Storage A
Excipient Y	67890	XYZ Distributors	02/03/2025	Storage B

Annexure-2: Labeling Verification Form

Material Name	Batch Number	Label Verified By	Verification Date	Remarks
Active Ingredient X	12345	John Doe	01/03/2025	No Issues
Excipient Y	67890	Jane Smith	02/03/2025	Label Missing Expiry Date

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