Calibration Program

1.0    Purpose        :       To provide the  detailed guidelines to follow the  calibration programmed 2.0   Objective      :        To establish & maintain a system for the calibration of all  The equipment’s used in the our organization. The accuracy & precision of such equipment’s is essential to assure reliability /  confidence in data obtained 3.0    Scope           :      Calibration program from -------.Pharmaceuticals Ltd, - 4.0   Responsibility      : §          Follow up               :                  Officer – QA §          Over all responsibility    :         Q.A Manager 5.0    Procedure : Each instrument / equipment must be calibrated as far as possible in the location where it will be used & under typical area conditions. Calibration shall be carried out at specified intervals. Instruments / equipment that are calibrated with each use are not included in the calibration program. Each instrument is tagged with a calibration sticker indicating the date of calibration signature        Of the person performing the calibration & the date when the next calibration is due. An instrument not conforming to established acceptable tolerances are repaired or replaced. Concerned department incharge should be informed about non- performance of any instrument such instrument is removed from service & identified with an “Under maintenance” tag attached to the equipment. Calibration logbook is maintained in which the data for every equipment / instrument is recorded. ·         Calibration program: - Ø            A master checklist for instituting the calibration program is prepared at the beginning of every year. This  list contains details like. o               Name of all the instruments in use in the departments. o               Model no. & name of manufacturer. o               Calibration frequency. o               Due dates for calibration. o               Name of persons responsible for calibration. The Q.A incharge review the calibration program on an annual basis. Review should include frequency of calibration, performance of instruments & review of calibration SOP’s. ·         Outside contractor calibration: - Ø      If outside contract calibration services are used, there should be written contracts or procedures to define the scope & responsibility of the services. The stores in charge shall approve calibration reports from contract calibration agency. ·           Calibration standards: - Ø     Equipment used for calibration of instrument shall be both calibrated in house using recognized standards and if calibrated by an outside agency, the calibration must be supported by certificate from the agency. ·         Calibration procedure: - Ø     Calibration procedure should contain the following information. Ø      The step-by-step procedures used for calibration. Ø      Responsibility for calibration & approval. Ø       Acceptance criteria must be established for the equipment being  calibrated    depend upon the accuracy & range of use of the equipment, which must be mentioned     in the SOP. Ø       Every calibration report must have the following information. o              Description of the instrument. o                     Range / Accuracy / least count. o                     Standard used. o                     Calibration date o                     Calibration status (Accepted / Rejected) o             Next calibration due date. o             Name & signature of the person performing the calibration. o             Name & signature of the person approving the calibration report. ·         Instrument maintenance records: - Ø              Details of instruments / equipment that are requires to be services or repairs are                        maintained in instrument maintenance logbook. Ø             After repairs an instrument should be re-calibrated. Ø            If an instrument is malfunctioning or requires non-routine maintenance, the officer responsible for calibration of that instrument should generate work order. The instrument maintenance logbook is used to include the following information after the repairs. o       Equipment Name o       Date of repaired. o       Nature of repair work carried out. o       Re-Calibration date. o       Signature of officer. ·         Instrument use records: - ·        Instrument use logbook is used to record the following information. ·        Calibration status calibration date & due date. 6.0   Reference documents  : not applicable   7.0   Copies to / Distribution Sites ·                   Quality Assurance ·                   All Department 8.0   Abbreviations & Important definition  ·    QA   =  Quality Assurance department ·    SOP =  Standard Operating Procedure            9.0   Review History Sr. No. Previous Revision No. New Rev. No. Review Date Reason For Review Change Control No. Approved By