Standard Operating Procedure for Handling and Storage of Active Pharmaceutical Ingredients (APIs) for Creams

Department	Creams
SOP No.	SOP/CRM/004/2025
Supersedes	SOP/CRM/004/2022
Page No.	Page 1 of 7
Issue Date	15/03/2025
Effective Date	20/03/2025
Review Date	15/03/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to ensure the proper handling and storage of Active Pharmaceutical Ingredients (APIs) used in the formulation of creams. This SOP establishes procedures for the safe handling, storage, and traceability of APIs to ensure the quality and integrity of the ingredients are maintained and that they comply with regulatory and GMP standards.

2. Scope

This SOP applies to all Active Pharmaceutical Ingredients (APIs) used in the production of creams within the Creams Department. It covers the processes of receiving, storing, handling, and transferring APIs throughout their lifecycle in the manufacturing process.

3. Responsibilities

• Warehouse Personnel: Responsible for receiving, inspecting, and labeling APIs according to their specifications. They ensure that the storage areas are clean, organized, and secure.
• Production Team: Responsible for handling APIs safely during the formulation process and ensuring that the correct API is used for each batch.
• Quality Control (QC): Verifies that APIs meet the required quality standards and conducts periodic checks to ensure that APIs are stored and handled according to the SOP.
• Quality Assurance (QA): Ensures that the handling and storage of APIs comply with GMP guidelines and regulatory standards. QA also performs audits and reviews to ensure continuous compliance with this SOP.

4. Accountability

The Head of Creams Manufacturing is accountable for ensuring that this SOP is followed during the handling and storage of APIs. Compliance with the API storage and handling procedures is ultimately the responsibility of the Quality Assurance (QA) Manager.

5. Procedure

5.1 Receiving and Inspection of APIs

1. Upon receipt of APIs, Warehouse Personnel must verify the shipment against the Purchase Order (PO) and the Material Identification Log to ensure the correct API and quantity are delivered.
2. Inspect the APIs for any signs of damage or contamination during transport. Ensure that the packaging is intact and that the labels are clear, legible, and securely affixed to the containers.
3. If any discrepancies are found in the API delivery, such as incorrect materials, damaged packaging, or missing documentation, Warehouse Personnel must notify the QA team immediately. The API will be placed in quarantine until the issue is resolved.

5.2 Labeling of APIs

1. Once the API is inspected and verified, it must be labeled with the following information:
   • Material Name
   • Batch or Lot Number
   • Manufacturing Date
   • Expiry Date (if applicable)
   • Storage Instructions (e.g., “Keep in a cool, dry place”)
   • Handling Precautions (e.g., “Handle with care; avoid moisture exposure”)
2. Ensure that the label is clear, durable, and permanently affixed to the container to prevent mix-ups during storage and handling.

5.3 Storage of APIs

1. APIs should be stored in designated storage areas that are clean, dry, and secure. Each API should be stored according to its specific requirements, such as temperature-sensitive APIs being placed in temperature-controlled rooms or cold storage.
2. Storage areas must be clearly labeled and organized, with appropriate signage indicating the types of materials stored in each area. APIs should be stored in a manner that prevents cross-contamination, and each container should be placed on shelves to avoid direct contact with the floor.
3. Ensure that APIs are stored in accordance with their respective safety data sheets (SDS) and material specifications. For hazardous APIs, appropriate safety measures such as spill containment kits and personal protective equipment (PPE) must be available in the storage area.

5.4 Handling of APIs

1. When handling APIs, ensure that the correct handling precautions are followed as per the API’s safety data sheet (SDS). Personnel must wear appropriate PPE such as gloves, masks, and lab coats to minimize exposure to potentially harmful substances.
2. During the handling process, ensure that APIs are protected from contamination. Avoid direct contact with skin or clothing, and always use clean, dedicated utensils for transferring materials.
3. If any material is spilled during handling, clean it immediately using appropriate spill containment procedures. Document the spill and notify the QA team for further investigation if necessary.

5.5 Transfer of APIs

1. When transferring APIs from the storage area to the production area, ensure that the material is securely sealed and labeled correctly. The transfer should be documented, including the material name, batch number, quantity, and date of transfer.
2. Transfer of APIs should be performed by authorized personnel only. If the API is moved to another location within the storage area, the transfer should be logged, and the storage location should be updated in the inventory system.

5.6 Regular Audits and Inspections

1. QC and QA teams will perform regular audits and inspections of the API storage areas to ensure compliance with this SOP and regulatory requirements. The inspections should include checks on labeling, storage conditions, and handling practices.
2. Any discrepancies found during audits should be addressed immediately. Corrective actions should be documented and followed up by the QA team to ensure continuous compliance.

5.7 Documentation and Record-Keeping

1. Maintain detailed records of the receipt, inspection, storage, handling, and transfer of APIs. These records should include the API name, batch number, quantity, location, and dates of each activity.
2. Documentation should be reviewed regularly by the QA team to ensure completeness and accuracy. All records should be stored securely and be accessible for audits and regulatory inspections.

5.8 Final Review and Compliance Check

1. The QA team will conduct a final review of the API storage and handling records. This includes verifying that all procedures have been followed correctly and that the documentation is complete.
2. Any issues identified during the review should be addressed immediately, and corrective actions should be implemented. Once all procedures are confirmed to be in compliance, the API will be approved for use in cream formulation.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• API: Active Pharmaceutical Ingredient
• PO: Purchase Order
• SDS: Safety Data Sheet
• GMP: Good Manufacturing Practices

7. Documents

1. Material Receipt Log (Annexure-1)
2. API Storage and Handling Log (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 API Handling and Storage

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 Receipt Log

Material Name	Batch Number	Supplier	Receipt Date	Storage Location
Active Ingredient A	12345	ABC Suppliers	15/03/2025	Storage A
Active Ingredient B	67890	XYZ Distributors	16/03/2025	Storage B

Annexure-2: API Storage and Handling Log

Material Name	Batch Number	Handled By	Storage Location	Date
Active Ingredient A	12345	John Doe	Storage A	15/03/2025
Active Ingredient B	67890	Jane Smith	Storage B	16/03/2025

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