Standard Operating Procedure for Handling Controlled Substances in Dispensing
| Department | Capsule Manufacturing |
|---|---|
| SOP No. | SOP/CM/016/2025 |
| Supersedes | SOP/CM/016/2022 |
| Page No. | Page 1 of 7 |
| Issue Date | 01/02/2025 |
| Effective Date | 05/02/2025 |
| Review Date | 01/02/2026 |
1. Purpose
To define the procedures for handling controlled substances during the dispensing process in capsule manufacturing, ensuring compliance with regulatory requirements, and maintaining the security of controlled materials.
2. Scope
This SOP applies to all controlled substances used in capsule manufacturing, ensuring that they are handled, dispensed, and documented correctly to comply with regulatory and safety standards.
3. Responsibilities
- Manufacturing Personnel: Responsible for handling controlled substances in compliance with the procedures outlined in this SOP and ensuring that the materials are dispensed accurately and securely.
- Quality Control (QC) Team: Ensures that controlled substances are handled according to regulatory guidelines, verifies that the correct substances are dispensed, and confirms compliance with quality standards.
- Quality Assurance (QA) Team: Ensures compliance with regulatory requirements for controlled substances and oversees the documentation and reporting of controlled substances dispensed.
- Security Personnel: Ensures that controlled substances are stored securely and are only accessible to authorized personnel.
4. Accountability
The Manufacturing Supervisor is accountable for ensuring that controlled substances are handled according to the SOP. The QA Manager is responsible for overseeing compliance with regulations and ensuring that all documentation is properly recorded.
5. Procedure
5.1 Handling Controlled Substances
Follow the steps below to ensure the proper handling of controlled substances during dispensing:
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Access Control
- Controlled substances must be stored in a secure area with limited access. Only authorized personnel with proper clearance should handle these substances.
- Ensure that a log is maintained for all personnel accessing the storage area, including their time and reason for access.
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Material Verification
- Before dispensing, verify the identity and quantity of the controlled substance by cross-checking the material’s label, batch number, and Certificate of Analysis (CoA) with the work order and batch record.
- Ensure that the material is physically checked for any tampering or damage before dispensing.
5.2 Dispensing Controlled Substances
Ensure the proper dispensing of controlled substances by following these steps:
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Pre-Dispensing Documentation
- Complete the necessary documentation before dispensing, including the work order reference, batch number, and quantities to be dispensed.
- Ensure that the controlled substance is logged in the Controlled Substance Dispensing Log (Annexure-1) with the date, time, quantity, and personnel involved in the dispensing.
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Dispense Using Secure Equipment
- Use tamper-proof and secured dispensing equipment to prevent unauthorized access during the dispensing process.
- Ensure that only the required amount is dispensed and the correct material is used for the formulation.
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Barcode Scanning and Verification
- If barcode scanning technology is available, ensure that each controlled substance is scanned to verify the correct material and quantity before dispensing.
- Document the barcode scan results in the Material Dispensing Log (Annexure-2) to maintain traceability and ensure dispensing accuracy.
5.3 Post-Dispensing Verification
Verify that the dispensing process has been completed correctly:
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Review Dispensing Records
- After dispensing, verify the dispensing records against the actual material quantities used and ensure that all data matches the work order and batch record.
- Confirm that all required fields in the Material Dispensing Log (Annexure-2) are completed, including the date, time, personnel involved, and any discrepancies noted during dispensing.
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Confirm Correct Quantity Dispensed
- If there are any discrepancies between the amount dispensed and the amount recorded, stop further dispensing and investigate the issue immediately.
- Document any discrepancies in the Discrepancy Report (Annexure-3) and initiate corrective actions as necessary.
5.4 Security and Storage of Controlled Substances
Ensure the proper storage and security of controlled substances:
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Secure Storage Area
- Store all controlled substances in a locked, secure area that is accessible only to authorized personnel. Ensure that access is monitored and documented.
- Verify that the security system (e.g., access logs, surveillance cameras) is operational and regularly maintained.
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Inventory Management
- Regularly update the inventory system to reflect the quantities of controlled substances in stock and dispensed.
- Conduct periodic physical counts of controlled substances to ensure that inventory records are accurate and that no discrepancies are present.
5.5 Documentation and Record-Keeping
Ensure proper documentation for compliance and traceability:
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Controlled Substance Dispensing Log
- Document all controlled substance dispensing activities in the Controlled Substance Dispensing Log (Annexure-1), including material names, batch numbers, quantities dispensed, and personnel involved.
- Ensure that all entries are verified and signed by the dispensing operator and the QA team.
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Audit Trail
- Maintain an audit trail of all controlled substance transactions, including material receipt, dispensing, and final disposition.
- Ensure that the records are securely stored and easily accessible for audits and inspections by regulatory authorities.
5.6 Training and Compliance
Ensure that all personnel involved in handling controlled substances are properly trained:
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Initial and Ongoing Training
- Provide initial training for all personnel involved in the dispensing of controlled substances, covering procedures, security protocols, and regulatory requirements.
- Conduct regular refresher training sessions to ensure ongoing compliance with SOPs and regulatory standards.
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Compliance Monitoring
- Regularly monitor the compliance of dispensing personnel with the procedures outlined in this SOP.
- Address any non-compliance issues promptly and take corrective actions as necessary.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QC: Quality Control
- API: Active Pharmaceutical Ingredient
- CoA: Certificate of Analysis
- PO: Purchase Order
7. Documents
- Controlled Substance Dispensing Log (Annexure-1)
- Discrepancy Report (Annexure-3)
- Material Dispensing Log (Annexure-2)
8. References
- 21 CFR Part 1300 – Drug Enforcement Administration (DEA) – Controlled Substances Regulations
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
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 Dispensing Log
| Date | Material Name | Batch Number | Quantity Dispensed | Dispensed By |
|---|---|---|---|---|
| 03/02/2025 | API-789 | Batch 56789 | 200 mg | John Doe |
Annexure-2: Material Dispensing Log
| Date | Material Name | Batch Number | Quantity Dispensed | Dispensed By |
|---|---|---|---|---|
| 03/02/2025 | Excipient-456 | Batch 12345 | 500 g | John Doe |
Revision History:
| Revision Date | Revision No. | Revision DetailsAnnexure-3: Discrepancy Report
Revision History:
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