SOP for Handling Controlled Substances in Aerosol Manufacturing

Department	Aerosol
SOP No.	SOP/Aerosol/003/2025
Supersedes	SOP/Aerosol/003/2022
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 the safe and compliant handling of controlled substances in the aerosol manufacturing process. It ensures that all controlled substances are handled, stored, and disposed of according to the relevant regulatory requirements and GMP standards to prevent misuse, contamination, or unauthorized access.

2. Scope

This procedure applies to all personnel involved in the handling, storage, and disposal of controlled substances used in aerosol manufacturing at [Company Name]. It covers the procedures for receipt, verification, storage, and disposal of controlled substances, as well as related documentation requirements. This SOP does not apply to non-controlled substances or materials outside the scope of aerosol manufacturing.

3. Responsibilities

• Receiving Personnel: Responsible for inspecting controlled substances upon receipt and verifying that all documentation is correct.
• Warehouse Supervisor: Responsible for ensuring that controlled substances are stored securely and are properly labeled.
• Production Personnel: Responsible for handling controlled substances during the manufacturing process and ensuring compliance with handling procedures.
• Quality Control (QC) Team: Responsible for verifying the integrity of controlled substances and conducting necessary quality checks.
• Security Personnel: Responsible for monitoring access to areas where controlled substances are stored or used to prevent unauthorized access.

4. Accountability

The Production Manager is accountable for ensuring that this SOP is followed during the handling of controlled substances 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 Controlled Substances

1. Upon receipt, the receiving personnel shall verify that the controlled substance matches the purchase order in terms of quantity, type, and batch number.
2. Controlled substances must be accompanied by the appropriate documentation, including a Certificate of Analysis (COA) and any regulatory certificates as required by law.
3. Any discrepancies in the shipment, such as missing or damaged items, must be reported immediately to the Purchasing Department and the Warehouse Supervisor.
4. Record the details of the received controlled substances in the Controlled Substance Log, including material name, batch number, quantity, and receiving date.

5.2. Storage of Controlled Substances

1. Controlled substances must be stored in a secure, locked area with restricted access. The key or access code to this area should be held by authorized personnel only.
2. Controlled substances should be segregated from other materials and stored according to their specific storage requirements, such as temperature control or humidity levels.
3. Label all controlled substances with appropriate identification, including the batch number, quantity, and expiry date. Labels should be clear and legible to avoid confusion.
4. The Warehouse Supervisor is responsible for ensuring that storage areas are inspected regularly and that controlled substances are securely stored at all times.

5.3. Handling of Controlled Substances

1. When handling controlled substances, all personnel must wear appropriate personal protective equipment (PPE), including gloves, goggles, and lab coats.
2. Controlled substances should be dispensed or transferred only in the correct quantities as per the batch production requirements.
3. Ensure that the transfer of controlled substances between departments is documented and tracked in the Controlled Substance Transfer Log.
4. Only authorized personnel should be involved in the handling of controlled substances. Unauthorized access or misuse of materials must be reported immediately.

5.4. Disposal of Controlled Substances

1. Expired, damaged, or unused controlled substances should be disposed of in accordance with regulatory requirements and company procedures.
2. Controlled substances must be returned to the appropriate disposal facility, and a Disposal Log must be completed to document the quantity and type of substance disposed of.
3. All disposal activities must be witnessed by at least one authorized personnel member, and a record of the disposal should be kept for audit purposes.

5.5. Corrective and Preventive Actions (CAPA)

1. In case of any issues such as discrepancies in controlled substance handling, corrective actions must be initiated. This may include retraining personnel, reviewing supplier procedures, or revising internal controls.
2. Preventive actions should be implemented to mitigate the risk of future discrepancies or security breaches in controlled substance handling.

6. Abbreviations

• COA: Certificate of Analysis
• GMP: Good Manufacturing Practice
• CAPA: Corrective and Preventive Actions
• QC: Quality Control

7. Documents

1. Controlled Substance Receipt Log (Annexure-1)
2. Controlled Substance Transfer Log (Annexure-2)
3. Controlled Substance Disposal Log (Annexure-3)
4. Controlled Substance Inspection 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 1300-1399
• 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: Controlled Substance Receipt Log

Material Name	Batch No.	Quantity Received	Receiving Date	Received By
Example Controlled Substance	12345	50 kg	06/02/2025	Ravi Kumar

Annexure-2: Controlled Substance Transfer Log

Material Name	Batch No.	Quantity Transferred	Transfer Date	Transferred By
Example Controlled Substance	12345	20 kg	06/02/2025	Rajesh Patel

Annexure-3: Controlled Substance Disposal Log

Material Name	Batch No.	Quantity Disposed	Disposal Date	Disposed By
Example Controlled Substance	12345	10 kg	07/02/2025	Ravi Kumar

Annexure-4: Controlled Substance Inspection Log

Material Name	Batch No.	Inspection Date	Inspection Result	Inspector Name
Example Controlled Substance	12345	06/02/2025	Pass	Rajesh Patel

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 handling and disposal procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures