Standard Operating Procedure for Handling and Storage of Controlled Substances

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish procedures for the safe handling, storage, distribution, and disposal of controlled substances within the pharmaceutical manufacturing facility to prevent diversion, misuse, and ensure compliance with regulatory requirements.

2) Scope

This SOP applies to all activities involving controlled substances, including receipt, storage, dispensing, usage, and destruction within the facility premises.

3) Responsibilities

– Security Manager: Oversees the implementation of security measures and controls for controlled substances as per regulatory requirements.
– Quality Assurance (QA) Department: Ensures compliance with SOP and regulatory guidelines for handling and storage of controlled substances.
– Warehouse and Inventory Management Team: Manages receipt, storage, and distribution of controlled substances in accordance with documented procedures.

4) Procedure

4.1 Receipt of Controlled Substances
4.1.1 Receive controlled substances from approved suppliers or authorized personnel following documented procedures and security protocols.
4.1.2 Verify the accuracy of received quantities against purchase orders and shipping documents, and record receipt details in inventory records.
4.2 Storage Conditions
4.2.1 Store controlled substances in secure storage areas with restricted access, adequate lighting, temperature control, and appropriate environmental conditions.
4.2.2 Segregate controlled substances based on storage requirements (e.g., temperature-sensitive substances) and compatibility to prevent cross-contamination or degradation.
4.3 Inventory Management
4.3.1 Maintain accurate inventory records of controlled substances, including quantities received, dispensed, used, and remaining stock levels.
4.3.2 Conduct regular inventory audits and reconciliations to verify physical stock against documented inventory records and identify discrepancies.
4.4 Dispensing and Usage
4.4.1 Dispense controlled substances only to authorized personnel or departments following approved procedures and with appropriate documentation.
4.4.2 Record all dispensing activities, including quantities dispensed, recipient details, and purpose of use, in controlled substance dispensing logs or records.
4.5 Security Measures
4.5.1 Implement physical security measures, such as access control systems, security cameras, and alarm systems, to prevent unauthorized access to controlled substance storage areas.
4.5.2 Establish and enforce security procedures for handling controlled substances during transportation, transfer between storage areas, and disposal activities.
4.6 Handling and Use Procedures
4.6.1 Develop standardized procedures for the safe handling, manipulation, and use of controlled substances by authorized personnel.
4.6.2 Provide training to personnel involved in handling controlled substances on proper procedures, safety precautions, and emergency response protocols.
4.7 Documentation and Recordkeeping
4.7.1 Maintain detailed records of all transactions involving controlled substances, including receipts, transfers, dispensing, usage, and destruction.
4.7.2 Document any incidents, discrepancies, or deviations related to the handling or storage of controlled substances, along with corrective actions taken.
4.8 Controlled Substance Disposal
4.8.1 Dispose of expired, damaged, or unused controlled substances using authorized disposal methods in compliance with regulatory requirements.
4.8.2 Document disposal activities, including quantities disposed, disposal methods used, and disposal certificates or records obtained.
4.9 Audits and Inspections
4.9.1 Conduct periodic audits of controlled substance handling and storage practices to verify compliance with SOP and regulatory requirements.
4.9.2 Prepare for and participate in regulatory inspections related to controlled substance handling and storage, providing access to documentation and records as required.
4.10 Reporting
4.10.1 Prepare periodic reports summarizing controlled substance handling and storage activities, including compliance status, incidents reported, and corrective actions implemented.
4.10.2 Submit reports to the QA department for review, approval, and archiving as per document control procedures.

5) Abbreviations, if any

– SOP: Standard Operating Procedure
– QA: Quality Assurance

6) Documents, if any

– Controlled Substance Handling Procedures
– Controlled Substance Inventory Records
– Incident Reports

7) Reference, if any

– FDA Guidance for Industry: Drug Supply Chain Security Act (DSCSA)
– DEA Regulations: Title 21 CFR Part 1300-1399, Controlled Substances Act
– ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0