Standard Operating Procedure for Handling and Storage of Controlled Substances
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the secure handling, storage, and disposal of controlled substances within the pharmaceutical manufacturing facility to prevent unauthorized access, diversion, or misuse.
2) Scope
This SOP applies to all personnel involved in the handling, storage, and disposal of controlled substances within the pharmaceutical manufacturing facility. It covers procedures for receiving, storage conditions, access control, and disposal methods.
3) Responsibilities
– Security Department: Ensures physical security measures and access control for controlled substances.
– Quality Assurance (QA) Department: Ensures compliance with SOP and regulatory requirements.
– Production Department: Implements procedures for handling and storage of controlled substances during manufacturing operations.
4) Procedure
4.1 Receiving
4.1.1 Designate authorized personnel to receive controlled substances shipments.
4.1.2 Verify received quantities and documentation against purchase orders and shipping manifests.
4.2 Storage Conditions
4.2.1 Store controlled substances in designated secure areas with restricted access.
4.2.2 Monitor and record storage conditions including temperature, humidity, and light exposure as applicable.
4.3 Access Control
4.3.1 Implement access control measures such as key card systems or biometric authentication for entry to storage areas.
4.3.2 Maintain a log of personnel accessing controlled substance storage areas and restrict access to authorized personnel only.
4.4 Inventory Management
4.4.1 Conduct regular inventory checks of controlled substances to ensure accurate stock levels.
4.4.2 Document inventory reconciliation and report any discrepancies to the QA department.
4.5 Dispensing and Use
4.5.1 Dispense controlled substances only to authorized personnel for approved manufacturing or testing purposes.
4.5.2 Record dispensing activities including quantities used, batch numbers, and recipient details.
4.6 Disposal
4.6.1 Develop and implement procedures for the safe disposal of expired, damaged, or unused controlled substances.
4.6.2 Dispose of controlled substances in compliance with local regulatory requirements and environmental guidelines.
4.7 Documentation
4.7.1 Maintain accurate records of controlled substance handling, storage, dispensing, and disposal activities.
4.7.2 Ensure that all records are reviewed and approved by the QA department.
4.8 Reporting
4.8.1 Prepare reports summarizing controlled substance inventory, usage, and disposal activities.
4.8.2 Submit reports to the QA department for review, approval, and archiving.
5) Abbreviations, if any
– QA: Quality Assurance
– SOP: Standard Operating Procedure
6) Documents, if any
– Controlled Substance Inventory Records
– Disposal Logs
– Access Control Logs
7) Reference, if any
– US Controlled Substances Act
– WHO Guidelines on the Safe Use of Controlled Substances in Healthcare
8) SOP Version
Version 1.0
