1. Equipment Selection
The process begins with identifying the need for new equipment. Various factors such as operational requirements, capacity, regulatory compliance, and budgeting are considered during the selection phase.
2. Qualification and Installation
Once an equipment is selected, it undergoes qualification and installation. This includes verifying that it meets the necessary regulatory standards, performing performance qualification (PQ) tests, and ensuring proper installation in accordance with manufacturer's guidelines.
3. Calibration and Validation
Regular calibration of equipment is vital to maintain accuracy and reliability. The workflow involves scheduling the calibration activities, performing the necessary tests, and documenting the results. Validation is also a crucial step, which involves ensuring that the equipment consistently produces results within predetermined specifications.
4. Preventive Maintenance
Preventive maintenance is essential to prevent unexpected breakdowns and extend the lifespan of equipment. This stage involves creating a maintenance schedule, conducting routine inspections, performing necessary cleaning, lubrication, and replacement of components, and documenting all maintenance activities.
5. Repairs and Corrective Maintenance
In the event of a breakdown, a process for repairs and corrective maintenance is implemented. This requires prompt identification of the issue, ordering replacement parts, coordinating repairs or troubleshooting, and ensuring equipment functionality is restored within acceptable timeframes.
6. Documentation and Record Keeping
Throughout the equipment lifecycle, the pharmaceutical industry places a great emphasis on documentation. It is crucial to maintain detailed records of all equipment-related activities such as maintenance, calibration, repairs, and training. This documentation is necessary for audit purposes, compliance with regulatory requirements, and facilitating continuous improvement efforts.
7. Upgrades and Retirement
As technology advances or operational needs change, equipment may become outdated or inefficient. Upgrades may be necessary to improve productivity, enhance safety, or comply with new regulations. Eventually, equipment reaches the end of its useful life and requires retirement or disposal. Suitable methods that comply with environmental regulations must be employed at this stage.
8. Training and Competency
Throughout the lifecycle, training is provided to personnel involved in equipment management. This ensures they are competent in using, maintaining, and troubleshooting the equipment. Regular training sessions keep employees updated with the latest regulatory requirements and industry best practices.
Read also:
