QAS-031 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 503

abc Pharmaceutical comPany

ANNEXURE D (FOR STERILE)
STERILE BULK MANUFACTURING FACILITY
SELF-EVALUATION QUESTIONNAIRE

6th Calibration Control (Manufacturing/Laboratory) Yes No N/A

1. Are there acceptable procedures to assure that gauges, tools, and

test equipment are maintained in proper order?   

2. If calibration is performed by the facility, are there calibration

procedures formalized?   

3. Is there a system to assure that gauges and testing equipment are

calibrated on time by responsible personnel?   

4. If computer software is used for scheduling preventative maintenance

and calibrations, is it validated?   

Comments :

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