Calibration Of Equipment Sop

Calibration shall be done using certified calibration standards traceable to national nist standards either in house or from a certified outside agency.

Calibration of equipment sop.

The calibration program is one of the key quality systems for successful gmp operations as well as for ensuring compliance during regulatory inspections. Hb 145 was developed as a source of calibration procedures for weights and measures laboratories and covered mass length and volume calibrations for field. Nbs handbook 145 1986 handbook for the quality assurance of metrological measurements by john k. Oppermann is out of print and the majority of content has been updated and published in the publications noted below.

The calibration system as laid out in 21 cfr 211 68 is mandatory for automatic mechanical and electronic equipment. 6 3 1 qa managers supervisors shall include procedures for calibration and or performance verification of new equipment in section technical procedures. Sop 1103 12 equipment maintenance calibration effective 7 20 page 2 of 2. The purpose of this sop to deal with the calibration of instruments glassware equipment thermometers etc.

7 8 calibration procedures 7 8 1 calibration procedures must be application specific and prescribe step by step instructions for calibration of measurement and test equipment or categories thereof. 5 17 if the instrument equipment fail in calibration test stop usages of the instrument equipment and put under maintenance label duly filled. Glass bead sterilizers annually and memorialized by a written. Equipment planner shall contain information like equipment name equipment id location calibration date next calibration due date and signatures.

4 3 newly purchased equipment shall be calibrated and shall be incorporated in calibration planner. 5 18 in case the critical instrument equipment fails in calibration such failure shall be reported to the head qa through the incident report and same shall be investigated as per sop for. This sop is applicable to the calibration of instrument equipment maintained by the quality control department in the pharmaceutical product manufacturing plant. 4 4 calibration shall be carried out in house or by contracted external agencies.

A robust calibration program is the basis for all operations associated with any quality related measurement. 6 3 2 calibration procedures shall be appropriate for the intended use of the equipment and shall provide criteria for determining if calibration is satisfactory. The purpose of this sop standard operating procedure is to describe the procedure for the calibration schedule and calibration practices of instrument equipment. Taylor and henry v.