SOP Guide for Pharma

SOP for Segregation of Pharmaceutical Waste

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SOP for Segregation of Pharmaceutical Waste

Standard Operating Procedure for Segregation of Pharmaceutical Waste

1) Purpose

The purpose of this SOP is to ensure proper segregation of pharmaceutical waste at the point of generation to minimize risks to human health and the environment and comply with applicable regulatory standards.

2) Scope

This SOP applies to all pharmaceutical waste generated in laboratories, manufacturing areas, warehouses, hospitals, and other healthcare facilities.

3) Responsibilities

  • Supervisors: Ensure proper segregation practices are followed and provide staff training.
  • Employees/Operators: Identify, segregate, and store pharmaceutical waste as per this SOP.
  • Safety Officers: Monitor segregation practices, conduct periodic audits, and provide corrective measures.
  • Waste Management Personnel: Ensure proper collection, storage, and transportation of segregated pharmaceutical waste.

4) Procedure

4.1 Categories of Pharmaceutical Waste

Pharmaceutical waste must be classified into the following categories for effective segregation:

  1. Non-Hazardous Pharmaceutical Waste:
    • Non-contaminated empty medicine bottles, vials, and packaging materials.
    • Expired over-the-counter (OTC) medications that are not hazardous.

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  2. Hazardous Pharmaceutical Waste:
    • Cytotoxic and cytostatic drugs (e.g., chemotherapy agents).
    • Expired or unused hazardous medications such as controlled substances.
    • Heavy metal-containing pharmaceuticals (e.g., mercury in thermometers).
  3. Infectious Pharmaceutical Waste:
    • Used IV bags, syringes, and needles contaminated with infectious drugs.
    • Contaminated gloves, gauze, and packaging.
  4. Sharps Waste:
    • Used syringes, needles, scalpels, and broken glass from pharmaceutical processes.
  5. Controlled Substances:
    • Drugs that require secure disposal as per regulatory guidelines
(e.g., narcotics).

4.2 Waste Segregation Process

Pharmaceutical waste must be segregated at the point of generation into clearly labeled and color-coded containers:

  1. Color Coding:
    • Yellow Containers: Hazardous pharmaceutical waste (cytotoxic, cytostatic).
    • Red Containers: Infectious waste (contaminated items like IV bags, gloves).
    • White/Blue Containers: Non-hazardous pharmaceutical waste (expired medicines).
    • Puncture-Proof Sharps Containers (Yellow/Red): Sharps waste (needles, syringes, glass).
    • Black Containers: Controlled substances and heavy metal-containing waste.

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  2. Labeling Requirements:
    1. Each container must have clear labels, including:
      • “Hazardous Pharmaceutical Waste,” “Infectious Waste,” or other appropriate designation.
      • Waste generation date.
      • Source/location of waste generation (e.g., Lab 1, Ward 2).
    2. Labels must be waterproof and non-erasable.
  3. Storage Before Disposal:
    1. Store waste in designated hazardous waste storage areas that are well-ventilated and secured.
    2. Do not overfill containers; replace them once 3/4 full to prevent spills or damage.
    3. Keep incompatible wastes (e.g., flammable and reactive) in separate storage areas.

4.3 Handling and Transport of Pharmaceutical Waste

  1. Internal Transport:
    • Use wheeled carts or trolleys to move pharmaceutical waste containers.
    • Ensure containers are tightly sealed and labeled before transport.

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  2. External Transport:
    • Coordinate with licensed waste disposal vendors for hazardous pharmaceutical waste.
    • Verify vendor credentials and maintain disposal manifests for audit purposes.

4.4 Disposal Methods

Different types of pharmaceutical waste must be disposed of using appropriate methods:

  1. Hazardous Waste:
    • Dispose through high-temperature incineration in authorized facilities.
    • Do not discharge hazardous pharmaceutical waste into drains or landfills.

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  2. Non-Hazardous Waste:
    • Send for secure landfill disposal or recycling where possible.
  3. Sharps Waste:
    • Dispose in authorized incinerators or autoclave prior to disposal.
  4. Controlled Substances:
    • Dispose under strict supervision with documentation and witness approval.
    • Follow local regulatory requirements for controlled substance destruction.

4.5 Record-Keeping

  1. Maintain accurate records of pharmaceutical waste segregation and disposal, including:
    • Type and quantity of waste
    • Disposal method and vendor details
    • Date and location of disposal

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  2. Use the Waste Segregation Log (Annexure 1) and maintain records for a minimum of five years.

4.6 Training and Awareness

  1. Train employees annually on waste segregation procedures, color coding, and disposal processes.
  2. Display waste segregation charts in all areas generating pharmaceutical waste.

5) Abbreviations, if any

  • PPE: Personal Protective Equipment
  • SDS: Safety Data Sheet
  • EPA: Environmental Protection Agency

6) Documents, if any

  • Waste Segregation Log
  • Waste Disposal Manifest

7) Reference, if any

  • WHO Guidelines on Safe Management of Waste from Health-Care Activities
  • EPA Resource Conservation and Recovery Act (RCRA)
  • OSHA Hazardous Waste Standards (29 CFR 1910.120)

8) SOP Version

Version: 1.0

Annexure

Template 1: Waste Segregation Log
Date Category Quantity Container Color Disposal Method Handled By
DD/MM/YYYY Hazardous (Cytotoxic) 5 kg Yellow Incineration John Doe
See also  SOP for Managing Radioactive Materials
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