Standard Operating Procedure for Equipment Lifecycle Management
1) Purpose
The purpose of this SOP is to establish procedures for managing the lifecycle of equipment used in the manufacturing of dental dosage forms, including pastes, gels, and mouthwashes. Equipment lifecycle management ensures optimal performance, regulatory compliance, and cost-effective maintenance throughout the equipment’s operational lifespan.
2) Scope
This SOP applies to all equipment and machinery used in pharmaceutical manufacturing processes for dental dosage forms. It includes procedures for equipment planning, acquisition, installation, operation, maintenance, qualification, decommissioning, and disposal.
3) Responsibilities
The Engineering Department is responsible for implementing and overseeing equipment lifecycle management activities. The Production Department is responsible for equipment operation, while the Maintenance Department handles maintenance and calibration. The Quality Assurance (QA) Department provides oversight and ensures compliance with regulatory requirements. All personnel involved in equipment lifecycle management are responsible for following these procedures and reporting any deviations promptly.
4) Procedure
4.1 Equipment Planning and Acquisition
4.1.1 Define equipment requirements based on production needs, capacity planning, and regulatory standards.
4.1.2 Prepare equipment specifications, including technical requirements, performance criteria, and regulatory compliance.
4.1.3 Obtain necessary approvals for equipment acquisition, budget allocation, and procurement process.
4.2 Equipment Installation and Commissioning
4.2.1 Develop installation qualification (IQ) protocols to verify proper equipment installation according
4.2.2 Conduct equipment installation under supervision of qualified personnel and document installation activities.
4.2.3 Perform operational qualification (OQ) to ensure equipment functions as intended under specified operating conditions.
4.3 Equipment Operation and Maintenance
4.3.1 Establish preventive maintenance schedules based on equipment manufacturer’s recommendations and regulatory requirements.
4.3.2 Conduct routine maintenance, calibration, and inspection of equipment to ensure reliability and compliance.
4.3.3 Address equipment breakdowns promptly through corrective maintenance and document repair activities.
4.4 Equipment Qualification and Validation
4.4.1 Develop performance qualification (PQ) protocols to demonstrate equipment consistently produces desired results.
4.4.2 Execute PQ studies under defined process conditions and analyze results to confirm equipment suitability for intended use.
4.4.3 Document qualification activities, including protocols, reports, and approvals.
4.5 Equipment Decommissioning and Disposal
4.5.1 Define criteria and procedures for equipment decommissioning based on lifecycle stages or regulatory requirements.
4.5.2 Remove equipment from service, clean and decontaminate as necessary, and prepare for disposal or relocation.
4.5.3 Dispose of equipment components or materials according to environmental regulations and company policies.
4.6 Documentation and Record-Keeping
4.6.1 Maintain accurate and up-to-date equipment records, including equipment manuals, maintenance logs, qualification documents, and calibration records.
4.6.2 Store documentation in a secure and accessible manner to facilitate audits, inspections, and equipment history tracking.
5) Abbreviations, if any
SOP – Standard Operating Procedure
IQ – Installation Qualification
OQ – Operational Qualification
PQ – Performance Qualification
QA – Quality Assurance
6) Documents, if any
Equipment Specifications
IQ, OQ, PQ Protocols
Maintenance Schedules
Equipment Qualification Reports
Decommissioning Records
7) Reference, if any
Good Manufacturing Practices (GMP) guidelines
International Organization for Standardization (ISO) standards for equipment management
Regulatory requirements for equipment qualification and validation
8) SOP Version
Version 1.0
