Standard Operating Procedure for GMP Compliance in Equipment Handling
1) Purpose
The purpose of this SOP is to establish procedures for the compliant handling and operation of equipment used in the manufacturing of dental dosage forms, ensuring adherence to Current Good Manufacturing Practices (cGMP) and regulatory requirements.
2) Scope
This SOP applies to all equipment handling activities conducted during the manufacturing, maintenance, and cleaning processes of dental pastes, gels, and mouthwashes within the pharmaceutical industry.
3) Responsibilities
All personnel involved in equipment handling, including operators, technicians, and supervisors, are responsible for ensuring compliance with GMP standards outlined in this SOP. The Quality Assurance (QA) Department is responsible for monitoring and auditing equipment handling practices for adherence to cGMP.
4) Procedure
4.1 Equipment Setup and Preparation
4.1.1 Ensure that equipment is set up and prepared according to manufacturer’s instructions and standard operating procedures.
4.1.2 Verify cleanliness and suitability of equipment for the intended process before use.
4.2 Equipment Operation
4.2.1 Operate equipment strictly in accordance with documented procedures and operational parameters.
4.2.2 Monitor equipment performance and process parameters to ensure consistent product quality and adherence to specifications.
4.3 Equipment Cleaning and Maintenance
4.3.1 Perform regular cleaning and sanitization of equipment following approved procedures and using validated cleaning agents.
4.3.2 Schedule and perform preventive maintenance activities as per manufacturer’s recommendations and established schedules.
4.4 Changeover Procedures
4.4.1 Implement documented changeover procedures to prevent cross-contamination and ensure product integrity during equipment transitions.
4.4.2 Verify effectiveness of changeover procedures through visual inspections and documented checks.
4.5 Equipment Calibration and Validation
4.5.1 Calibrate equipment at defined intervals using calibrated instruments and traceable standards.
4.5.2 Validate equipment performance through qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
4.6 Documentation and Record-Keeping
4.6.1 Document all equipment handling activities, including setup, operation, cleaning, maintenance, and calibration.
4.6.2 Maintain accurate and up-to-date records in compliance with regulatory requirements and company policies.
5) Abbreviations, if any
SOP – Standard Operating Procedure
GMP – Good Manufacturing Practice
6) Documents, if any
Equipment Setup Procedures
Operational Procedures
Cleaning and Maintenance Logs
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
Company-specific equipment handling policies and procedures
8) SOP Version
Version 1.0