SOP Guide for Pharma

SOP for Disposal of Controlled Substances Waste

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SOP for Disposal of Controlled Substances Waste

Standard Operating Procedure for Disposal of Controlled Substances Waste

1) Purpose

The purpose of this SOP is to establish guidelines for the safe, secure, and compliant disposal of waste containing controlled substances to prevent misuse, environmental contamination, and ensure adherence to regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the handling, storage, and disposal of controlled substances waste generated during manufacturing, research, or healthcare activities.

3) Responsibilities

  • Supervisors: Ensure proper implementation of controlled substance disposal procedures.
  • Authorized Personnel: Handle and document all controlled substance waste disposal activities.
  • Compliance Officers: Verify that disposal practices comply with local regulations and organizational policies.
  • Waste Management Team: Oversee secure storage, transport, and destruction of controlled substances.

4) Procedure

4.1 Classification of Controlled Substances Waste

Controlled substances waste is classified as follows:

  1. Expired Substances: Drugs past their expiration date.
  2. Residuals: Leftovers in vials, ampoules, or syringes.
  3. Contaminated Materials: Gloves, syringes, or containers exposed to controlled substances.
  4. Manufacturing Waste: Spillage, rejects, or off-specification batches.
See also  SOP for Incineration of Pharmaceutical Waste

4.2 Secure Storage of Controlled Substances Waste

  1. Designated Storage Areas:
    • Store waste in a locked and secure area with restricted access.
    • Label storage cabinets or containers with “CONTROLLED SUBSTANCE WASTE” and include hazard warnings.

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  2. Segregation:
    • Keep controlled substances waste separate from other waste streams to avoid contamination or unauthorized access.
    • Use
tamper-evident containers for storing high-risk waste such as opioids or sedatives.
  • Inventory Records:
    • Maintain a log of all controlled substances waste, including type, quantity, and storage details (Annexure 1).

    • 4.3 Disposal Authorization

    1. Regulatory Compliance:
      • Follow disposal guidelines issued by local regulatory authorities such as the DEA (Drug Enforcement Administration) or equivalent agencies.
      • Obtain written approval for disposal from the Compliance Officer or regulatory body.

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    2. Authorized Personnel:
      • Ensure only authorized personnel handle and oversee controlled substance waste disposal.

    4.4 Methods of Disposal

    1. Destruction by Incineration:
      • Send controlled substances waste to an authorized incineration facility.
      • Ensure incineration is conducted at high temperatures to completely destroy active compounds.

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    2. Chemical Neutralization:
      • Use approved chemical methods to neutralize controlled substances before disposal.
      • Dispose of neutralized waste through authorized hazardous waste disposal channels.
    3. Return to Manufacturer (if applicable):
      • Coordinate with the manufacturer for the return and destruction of controlled substances waste.

    4.5 Documentation and Record-Keeping

    1. Waste Disposal Log:
      • Record details of waste disposal, including type, quantity, date, and disposal method, in the Controlled Substances Waste Disposal Log (Annexure 2).

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    2. Disposal Certificates:
      • Obtain disposal certificates from authorized vendors or incineration facilities.
      • Retain certificates for a minimum of 5 years for compliance audits.

    4.6 Audits and Inspections

    1. Internal Audits:
      • Conduct regular audits to ensure adherence to controlled substance disposal practices.
      • Document audit findings and corrective actions in the Audit Report Log (Annexure 3).

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    2. Regulatory Inspections:
      • Prepare all records and waste samples for inspection by regulatory authorities.

    4.7 Emergency Procedures

    1. Spills:
      • Contain spills using spill kits and absorbent materials.
      • Dispose of contaminated cleanup materials as hazardous waste.

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    2. Unauthorized Access:
      • Report any unauthorized access to controlled substances waste storage to the Compliance Officer immediately.
      • Review and reinforce access control measures.

    5) Abbreviations, if any

    • DEA: Drug Enforcement Administration
    • PPE: Personal Protective Equipment

    6) Documents, if any

    • Controlled Substances Waste Log
    • Disposal Certificates
    • Audit Report Log

    7) Reference, if any

    • DEA Disposal Guidelines for Controlled Substances
    • Hazardous Waste Management Rules, 2016
    • EPA Resource Conservation and Recovery Act (RCRA)

    8) SOP Version

    Version: 1.0

    Annexure

    Template 1: Controlled Substances Waste Log
    Date Waste Type Quantity Storage Location Authorized Personnel
    DD/MM/YYYY Expired Opioids 5 Kg Secured Cabinet A John Doe

    Template 2: Waste Disposal Log
    Date Waste Type Quantity Disposal Method Vendor Name Certificate Number
    DD/MM/YYYY Residual Narcotics 2 Liters Incineration XYZ Disposal Services CERT-12345

    Template 3: Audit Report Log
    Date Audit Area Findings Corrective Action Auditor Name
    DD/MM/YYYY Storage Area Label missing on one container Updated label immediately Jane Smith
    See also  SOP for Conducting Post-Incident Investigations
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