Standard Operating Procedure for Handling and Disposal of Waste in Granules Production

1) Purpose

The purpose of this SOP is to establish guidelines for the proper handling, segregation, and disposal of waste generated during granules production in the pharmaceutical industry to ensure environmental safety and regulatory compliance.

2) Scope

This SOP applies to all personnel involved in the handling and disposal of waste generated during granules production within the pharmaceutical manufacturing facility.

3) Responsibilities

Production Operators: Responsible for segregating waste at the point of generation.
Waste Management Team: Responsible for overseeing waste collection, treatment, and disposal.
Environmental Health and Safety (EHS) Department: Responsible for ensuring compliance with environmental regulations.

4) Procedure

1. Segregation of Waste:
   1. Segregate waste into categories (e.g., general waste, hazardous waste) at the point of generation using appropriate containers.
   2. Label containers clearly with waste type and hazard classification.
2. Storage of Waste:
   1. Store waste in designated storage areas that are secure and prevent leakage or spillage.
   2. Ensure waste containers are properly sealed and labeled to prevent cross-contamination.
3. Collection and Transport:
   1. Arrange for regular collection of waste by authorized waste management personnel.
   2. Transport waste to designated treatment or disposal facilities following regulatory requirements.
4. Disposal:
   1. Dispose of waste through authorized waste treatment facilities or contractors as per regulatory guidelines.
   2. Maintain records of waste disposal activities including manifests and certificates of disposal.
5. Training:
   1. Provide training to personnel involved in waste handling on proper segregation, storage, and disposal practices.
   2. Ensure awareness of regulatory requirements and safety protocols.
6. Documentation:
   1. Maintain comprehensive records of waste generation, handling, and disposal activities.
   2. Review and archive records in accordance with document control procedures.

5) Abbreviations, if any

SOP: Standard Operating Procedure
EHS: Environmental Health and Safety

6) Documents, if any

Waste Management Plan, Waste Disposal Records

7) Reference, if any

Environmental Protection Agency (EPA) guidelines and local waste management regulations.

8) SOP Version

Version 1.0