Calibration Of Equipment Sop

Taylor and henry v.

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 3 newly purchased equipment shall be calibrated and shall be incorporated in calibration planner. 6 3 1 qa managers supervisors shall include procedures for calibration and or performance verification of new equipment in section technical procedures. 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. 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. A robust calibration program is the basis for all operations associated with any quality related measurement.

4 4 calibration shall be carried out in house or by contracted external agencies. Calibration shall be done using certified calibration standards traceable to national nist standards either in house or from a certified outside agency. 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. Glass bead sterilizers annually and memorialized by a written.

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 program is one of the key quality systems for successful gmp operations as well as for ensuring compliance during regulatory inspections. Equipment planner shall contain information like equipment name equipment id location calibration date next calibration due date and signatures. The calibration system as laid out in 21 cfr 211 68 is mandatory for automatic mechanical and electronic equipment.

Calibration sop of respective instrument equipment shall mention the calibration schedule and acceptance criteria. Sop 1103 12 equipment maintenance calibration effective 7 20 page 2 of 2. This sop is applicable to the calibration of instrument equipment maintained by the quality control department in the pharmaceutical product manufacturing plant. These shall be prepared internally by another agency the manufacturer or a composite of any of these.