SOP for Receiving Raw Materials for Aerosol Dosage Forms

Department	Aerosol
SOP No.	SOP/Aerosol/001/2025
Supersedes	SOP/Aerosol/001/2022
Page No.	Page 1 of Y
Issue Date	06/02/2025
Effective Date	16/02/2025
Review Date	06/02/2028

1. Purpose

This Standard Operating Procedure (SOP) outlines the procedures for receiving raw materials used in the manufacture of aerosol dosage forms. It ensures that all materials meet the required quality standards and are received in compliance with Good Manufacturing Practices (GMP). This SOP is essential for maintaining the integrity of the materials used and ensuring that only approved, quality raw materials are used in the manufacturing process.

2. Scope

This procedure applies to all personnel involved in the receiving and inspection of raw materials for aerosol dosage forms at [Company Name]. It covers the receipt of raw materials, their initial inspection, and documentation, ensuring that materials are properly handled and stored until they are ready for use in production. This SOP does not apply to the handling of finished products or materials in other departments.

3. Responsibilities

• Receiving Personnel: Responsible for inspecting raw materials upon receipt, ensuring that materials are correctly labeled, and documenting their acceptance or rejection based on the inspection criteria.
• Quality Control (QC) Team: Responsible for performing any additional testing on the raw materials as required and ensuring that materials meet the quality standards.
• Warehouse Supervisor: Ensures that raw materials are properly stored in the designated areas and that stock levels are appropriately managed.
• Purchasing Department: Responsible for coordinating with suppliers to ensure timely delivery of the correct materials.

4. Accountability

The Warehouse Manager is accountable for ensuring that this SOP is followed during the receipt of raw materials and that any deviations are addressed. The overall compliance to this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Receipt of Raw Materials

1. Upon arrival of raw materials at the facility, the receiving personnel shall inspect the shipment for any visible damage. If any damage is noted, it must be reported immediately to the Warehouse Manager.
2. Check the delivery note to ensure that the correct materials and quantities have been received. Compare the information with the purchase order to confirm that there is no discrepancy.
3. If discrepancies are found, the Purchasing Department shall be notified to resolve the issue. A discrepancy report should be completed and filed for record-keeping.

5.2. Labeling and Identification

1. Each raw material container must be labeled with the following information: material name, batch number, expiry date, supplier details, and any other relevant identifiers.
2. If labeling is missing or incorrect, the raw material shall be quarantined and not used until the issue is resolved. The relevant supplier should be contacted for clarification.

5.3. Inspection and Documentation

1. The QC team shall conduct an initial inspection of the raw materials. This includes checking the physical condition of the materials, such as moisture content, color, texture, and packaging integrity.
2. QC personnel must verify the Certificate of Analysis (COA) provided by the supplier to ensure the material complies with the specifications. Any issues identified must be documented and investigated.
3. Complete a Material Receipt Log to record details of the received materials, including batch number, quantity, and date received.

5.4. Storage of Raw Materials

1. Upon acceptance, the raw materials should be stored in the designated areas as per their storage conditions. These areas must be clean, dry, and free from contaminants.
2. The raw materials must be segregated by type, ensuring that incompatible materials are stored separately. Materials requiring special storage conditions, such as temperature control, should be placed in the designated controlled areas.
3. The Warehouse Supervisor is responsible for ensuring that stock levels are monitored and materials are used in a first-in, first-out (FIFO) manner.

5.5. Testing and Verification

1. For materials that require additional testing, the QC team will conduct tests as specified in the material specification sheet. All test results must be documented in the relevant logs.
2. Any materials that fail the inspection or testing process shall be rejected and returned to the supplier with appropriate documentation outlining the reasons for rejection.

5.6. Corrective and Preventive Actions (CAPA)

1. In case of a failure in material inspection or discrepancy in delivery, corrective actions should be initiated to address the root cause of the issue. This may involve reviewing the supplier’s quality control processes, adjusting internal procedures, or enhancing training programs for receiving personnel.
2. Preventive actions should be implemented to prevent the recurrence of similar issues. This may include changes to supplier selection criteria or enhanced material inspection protocols.

6. Abbreviations

• COA: Certificate of Analysis
• GMP: Good Manufacturing Practice
• QC: Quality Control
• FIFO: First-In, First-Out

7. Documents

1. Material Receipt Log (Annexure-1)
2. Certificate of Analysis (COA) (Annexure-2)
3. Discrepancy Report (Annexure-3)
4. Supplier Contact Log (Annexure-4)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

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 No.	Quantity Received	Inspection Date	Acceptance Status
Example Material	12345	100 kg	06/02/2025	Accepted

Annexure-2: Certificate of Analysis (COA)

Material Name	Batch No.	Supplier	COA Status
Example Material	12345	Supplier A	Verified

Annexure-3: Discrepancy Report

Discrepancy Description	Action Taken	Responsible Party	Resolution Date
Missing label	Supplier contacted for new labels	Ravi Kumar	07/02/2025

Annexure-4: Supplier Contact Log

Supplier Name	Contact Date	Issue Reported	Action Taken
Supplier A	06/02/2025	Missing label	Contacted for new labels

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated labeling and storage procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures