- Objective:To lay down a procedure for Calibration of equipments and instruments from external authorized Agencies / Supplier.
- Scope:This procedure shall be applicable for calibration of equipment / instrument of all the departments of pharmaceutical Company
- Head of Engineering: (i) For maintaining records (ii) For the selection of authorized calibration agency / Supplier
- Heads of Production, Engineering, Quality Control and all other Departments to ensure the equipment / instrument is used only after acceptable calibration status.
- Accountability:HeadEngineering and Qa shall be accountable for compliance of this SOP
- Abbreviations and Definitions:
- Authorized agency / Supplier – Agency / Supplier authorized to do calibration activities either from ‘National Accreditation Board of Testing and Calibration Laboratory’ or from ‘National Physical Laboratory’ or the agency which is doing calibrations with the master equipments / instruments traceable to national or international standards.
- All the instruments / equipment associated with the processing, monitoring and testing of products, materials and areas and do not have internal procedure to perform calibration shall be identified and shall be calibrated through authorized outside Agencies/Suppliers and same shall be approved by Head of Engineering and Head of Quality Assurance.
- List of Equipment / Instruments to be calibrated through External Agency (Annexure-I) shall be made. This list shall specify name of equipment, its identification no., make, model, range frequency of calibration and acceptance criteria same shall be sign with date by executive /Officer Engineering.
- A calibration planner (Annexure-II) shall be Prepared by Engineering department specifying the equipment / instrument name, identification number, calibration done on, next calibration due on. the same information shall be available on label titled ‘Calibration status’ as status ‘calibrated’ (Annexure-III) attached to the equipment.
- External agency / Supplier shall calibrate each Instrument / Equipment using calibrated Master Instrument / Equipment, traceable to the National or International standards and prepare a calibration report. After receipt of the Calibration Report the same shall be verified for informations like calibration standard, Name, Report No., Equipment identification number, Calibration done on, Next calibration due on and other relevant information if any. All such reports shall be maintained by Engineering Department for a period of at least five years from the date of calibration.
- Ensure that Instrument / Equipment send to out side and received after calibration from external Agencies / Suppliers shall be properly packed to avoid any damages.
- Calibration shall be carried out within 10 days from the calibration due date.During calibration machine can be run with Pre-calibrated spare equipment / instruments in place of original equipment / instrument.
- The calibration certificates obtained from outside agency / supplier, shall be evaluate for its adequacy and tolerance limit by the concerned department and countersigned by Engineering department (Annexure-IV. The evaluation report shall be attached with calibration certificate.
- If the instrument / equipment fails it shall be replace / repair. In such case Executive / Officer Engineering shall inform the same to the Head of concerned department, who in turn along with Head of Quality Assurance shall investigate the effect of this failure on production and quality made in between the date of failure and earlier date of calibration. Quality Assurance shall maintain report of this.
- Forms and Annexure.
- List of Equipment / Instrument to be calibrated by External Agency – Annexure-I.
- Calibration Planner – Annexure-II.
- Calibration Status – Annexure-III.
- Evaluation Report – Annexure-IV.
- Master Copy – Documentation Cell.
- Controlled Copies: Engineering, Production, Quality Assurance,Quality Control, Engineering and Warehouse.
Reason for Revision
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube