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