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
- Upon receipt, the receiving personnel shall verify that the controlled substance matches the purchase order in terms of quantity, type, and batch number.
- Controlled substances must be accompanied by the appropriate documentation, including a Certificate of Analysis (COA) and any regulatory certificates as required by law.
- Any discrepancies in the shipment, such as missing or damaged items, must be reported immediately to the Purchasing Department and the Warehouse Supervisor.
- 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
- 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.
- Controlled substances should be segregated from other materials and stored according to their specific storage requirements, such as temperature control or humidity levels.
- Label all controlled substances with appropriate identification, including the batch number, quantity, and expiry date. Labels should be clear and legible to avoid confusion.
- 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
- When handling controlled substances, all personnel must wear appropriate personal protective equipment (PPE), including gloves, goggles, and lab coats.
- Controlled substances should be dispensed or transferred only in the correct quantities as per the batch production requirements.
- Ensure that the transfer of controlled substances between departments is documented and tracked in the Controlled Substance Transfer Log.
- 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
- Expired, damaged, or unused controlled substances should be disposed of in accordance with regulatory requirements and company procedures.
- 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.
- 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)
- 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.
- 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
- Controlled Substance Receipt Log (Annexure-1)
- Controlled Substance Transfer Log (Annexure-2)
- Controlled Substance Disposal Log (Annexure-3)
- 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 |