Calibration Of Equipment Sop

4 3 newly purchased equipment shall be calibrated and shall be incorporated in calibration planner.

Calibration of equipment sop.

Oppermann is out of print and the majority of content has been updated and published in the publications noted below. 4 4 calibration shall be carried out in house or by contracted external agencies. Sop 1103 12 equipment maintenance calibration effective 7 20 page 2 of 2. Taylor and henry v.

The purpose of this sop standard operating procedure is to describe the procedure for the calibration schedule and calibration practices of instrument equipment. This sop is applicable to all analytical and testing equipments instruments and glassware in quality control laboratory at pharmaceutical manufacturing industry. Calibration sop of respective instrument equipment shall mention the calibration schedule and acceptance criteria. Calibration shall be done using certified calibration standards traceable to national nist standards either in house or from a certified outside agency.

This sop is applicable to the calibration of instrument equipment maintained by the quality control department in the pharmaceutical product manufacturing plant. Hb 145 was developed as a source of calibration procedures for weights and measures laboratories and covered mass length and volume calibrations for field. 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 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.

The purpose of this sop to deal with the calibration of instruments glassware equipment thermometers etc. The calibration system as laid out in 21 cfr 211 68 is mandatory for automatic mechanical and electronic equipment. Nbs handbook 145 1986 handbook for the quality assurance of metrological measurements by john k. The calibration program is one of the key quality systems for successful gmp operations as well as for ensuring compliance during regulatory inspections.

These shall be prepared internally by another agency the manufacturer or a composite of any of these. Equipment planner shall contain information like equipment name equipment id location calibration date next calibration due date and signatures. Glass bead sterilizers annually and memorialized by a written. 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.