Calibration Of Equipment Sop

6 3 1 qa managers supervisors shall include procedures for calibration and or performance verification of new equipment in section technical procedures.

Calibration of equipment sop.

Oppermann is out of print and the majority of content has been updated and published in the publications noted below. 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 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.

This sop is applicable to all analytical and testing equipments instruments and glassware in quality control laboratory at pharmaceutical manufacturing industry. These shall be prepared internally by another agency the manufacturer or a composite of any of these. Hb 145 was developed as a source of calibration procedures for weights and measures laboratories and covered mass length and volume calibrations for field. Taylor and henry v.

Sop 1103 12 equipment maintenance calibration effective 7 20 page 2 of 2. 4 4 calibration shall be carried out in house or by contracted external agencies. Calibration sop of respective instrument equipment shall mention the calibration schedule and acceptance criteria. The calibration program is one of the key quality systems for successful gmp operations as well as for ensuring compliance during regulatory inspections.

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. The purpose of this sop standard operating procedure is to describe the procedure for the calibration schedule and calibration practices of instrument equipment. 5 17 if the instrument equipment fail in calibration test stop usages of the instrument equipment and put under maintenance label duly filled.

The calibration system as laid out in 21 cfr 211 68 is mandatory for automatic mechanical and electronic equipment. A robust calibration program is the basis for all operations associated with any quality related measurement. 4 3 newly purchased equipment shall be calibrated and shall be incorporated in calibration planner. This sop is applicable to the calibration of instrument equipment maintained by the quality control department in the pharmaceutical product manufacturing plant.