Calibration Program Summary

Below is a summary of ABC Pharmaceutical s Calibration Program, which is defined in related SOP(s). 

All process and facility instruments are classified as to their calibration status into one of the three following categories  

All instruments providing critical process information necessary to make a quality determination are calibrated with the available standards. 

ABC Pharmaceutical is in the process of procuring calibration standards. The Calibration Engineer will be responsible for scheduling, tracking, and maintenance of standards, records, etc. All standards will be traceable to NIST standards. 

Pre- and post-calibration of instruments utilized in validation studies are performed to ensure data accuracy. 

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

Calibration program summary. The instrument calibration program should describe calibration policy for validation of test equipment, pre- and post-calibration, and NIST traceability of calibration standards. The responsibility of calibration shall be defined. 

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. 

The Contract Laboratory Program procedure required delivery of specified documents included data summary forms, calibration data, chromatograms, and mass spectra and were generally shipped by air freight. Upon receipt by EPA, the documents were reviewed for data usability which was based on consideration of completeness of documentation and adherence to quality control requirements... 

This talk is a summary of the present status of that program. The program s goal is to make available several types of calibration standards to the gas industry by the end of 1985. These include a GC calibration mixture with direct NBS traceable certification of composition and similarly traceable calorimetric calibration standards with heating values in range of 800 to over 1200 Btu/SCF. 

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