Preventive Maintenance Program Summary

Below is a summary of key points of ABC Pharmaceutical s Preventive Maintenance Program, which is defined in related SOP(s). 

An appropriate Preventive Maintenance Program is defined for the equipment that will be checked at the time of validation. 

The Supervisor of the related area and the Engineer concerned will sign the register and verify if repairs are required. 

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Required Protocols and Procedures for Parenterals Production Calibration Program Summary Preventive Maintenance Program Summary Key SOPs... 

Preventive maintenance program summary. The preventive maintenance program should be summarized for the facility with responsibility for tracking. 

Required protocols and procedures for parenterals production Calibration program summary Preventive maintenance program summary Key SOPs... 

Utility and HVAC systems are among the easiest to address with respect to revalidation. Their performance is evaluated on a near continuous basis through the collection and testing of samples taken from the system. This affords a direct and ongoing assessment of the system s acceptability for use. Coupled with effective change control, calibration, and preventive maintenance programs, the collected data from the system should support its continued use. The preparation of summary reports on results from the system on a monthly or quarterly basis precludes the need for further evaluation. 

System calibration refers to the periodic operational qualification of the HPLC, typically every 6 to 12 months in most regulated laboratories. This calibration procedure is usually coordinated with an annual preventative maintenance (PM) program and is performed immediately after PM. A calibration sticker is placed on the instrument to indicate its calibration status and readiness for GMP work. The reader is referred to the principles and strategies behind HPLC calibration criteria published elsewhere.8 A summary of the calibration procedures and acceptance criteria, including additional procedures recommended for initial operational qualification, is listed in Table 9.3. 

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