Standard Operating Procedure for Maintenance of Weighing and Dispensing Equipment

1) Purpose

The purpose of this SOP is to establish guidelines for the maintenance and operation of weighing and dispensing equipment in pharmaceutical manufacturing facilities to ensure accurate and reliable weighing processes and product quality.

2) Scope

This SOP applies to all weighing and dispensing equipment used within the facility premises.

3) Responsibilities

The Facilities Management Department is responsible for implementing and adhering to this SOP. The Weighing and Dispensing Technician or designated personnel are responsible for the maintenance and operation of weighing and dispensing equipment.

4) Procedure

1. Preventive Maintenance
   1. Develop a preventive maintenance schedule for weighing and dispensing equipment based on manufacturer recommendations and operational requirements.
   2. Inspect equipment components such as balances, scales, dispensers, and software interfaces regularly for accuracy, calibration, and cleanliness.
2. Cleaning and Calibration
   1. Follow standard operating procedures for cleaning and calibrating weighing and dispensing equipment to maintain accuracy and prevent contamination.
   2. Use approved cleaning agents and calibration weights suitable for equipment materials and accuracy requirements.
3. Performance Verification
   1. Conduct performance verification tests to ensure weighing and dispensing equipment operates within specified parameters such as accuracy, repeatability, and linearity.
   2. Calibrate equipment as per calibration procedures and maintain calibration records.
4. Emergency Procedures
   1. Develop and maintain emergency response procedures for weighing and dispensing equipment malfunctions, accuracy deviations, or other incidents.
   2. Train personnel on emergency shutdown procedures and containment protocols.
5. Documentation and Reporting
   1. Maintain accurate records of equipment inspections, maintenance activities, performance tests, calibrations, and any adjustments made to the weighing and dispensing equipment.
   2. Document any incidents or deviations from standard operating procedures.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Preventive Maintenance Schedule, Cleaning and Calibration Procedures, Performance Verification Reports, Emergency Procedures Manual, Calibration Records

7) Reference, if any

Manufacturer’s recommendations for weighing and dispensing equipment maintenance, industry guidelines for weighing processes, regulatory requirements for equipment cleanliness and performance, and local safety regulations.

8) SOP Version

Version 1.0