Equipment Calibration and Vendor Coordination in India

Indian manufacturers typically undertake calibration in a reactive manner by verifying their instrumentation equipment either prior to an inspection by regulatory authorities or following discovery that a quality problem had occurred because of an error in the equipment. Reactive calibration often leads to backlog in calibration activities, out-of-tolerance equipment being used for manufacturing products, and even findings during audits that could have been avoided had there been proper calibration programme management in place. IMARC Engineering develops customised risk-based calibration programmes that identify every single piece of equipment by its importance to the quality and regulatory aspects of manufacturing processes. This includes assigning appropriate calibration frequencies based on the category and use of each instrument, along with a master calibration list identifying the status and due date for all instruments.

Calibration services available in India range from NABL-accredited labs to OEM-authorized calibration centers and a vast pool of unaccredited service providers, who do not provide calibration certificates which can be submitted to regulators due to non-traceability. Choosing the wrong calibration service provider results in instrument being calibrated on paper only but not holding certificates that will be acceptable at CDSCO, NABL audit or even international GMP audit for traceability of calibration process. IMARC Engineering screens the calibration service provider based on NABL accreditation coverage, traceability of calibration standards used (NPL traceable), documentation of measurement uncertainty and time factor and ensures that the generated certificate is acceptable to all regulations without any verification.

An average pharma, food, or chemical production plant in India will have anywhere from several to a hundred pieces of equipment for categories like analytical balances, HPLC and UV-Visible Spectrophotometer, Temperature & Humidity Measurement Instruments, Pressure Measurement Instruments, Flow Rate Measurement Instruments, pH & Conductivity Meters, Autoclave & Sterilizer Validation Instruments, and Process Control Equipment, all of which require calibration from a service provider capable of calibrating that category of instrument. Scheduling multiple service providers for different types of equipment calibration can be overwhelming, causing frequent scheduling issues and documentation errors. IMARC Engineering takes care of multi-service provider coordination under one umbrella and maintains an integrated schedule for all vendors and instruments under one programme and provides customers with a consolidated compliance view of their entire instrument inventory.

Calibration documents are considered the most analysed documents in GMP audits conducted by CDSCO auditors, WHO-GMP auditors, and certification bodies. Lack of documentation, absence of calibration certificates, out-of-tolerance not resolved, non-conformity between the calibration status label and master register entry, and certificates of vendors that are accredited for an instrumentation not covered by their scope, form audit findings that affect the facility's GMP status. IMARC Engineering develops calibration document system that conforms to GMP, NABL, and Legal Metrology documentations requirement, ensuring audit ready documents that are accurate and available without the need to recreate documentation before any audit.

The calibration regulation does not stop at the recalibration of the instrument itself; it also entails a documented evaluation of whether the readings made using that instrument after the previous calibration up until the time it was discovered to be out of tolerance could have been affected and whether those readings need to be evaluated for product quality, whether batches need to be recalled, and whether customers need to be notified. An evaluation of the impact of out-of-tolerance readings is probably one of the most overlooked aspects of calibration in Indian manufacturing organizations, leading to several audit non-conformances whenever an audit finds out-of-tolerance readings, but no impact assessment performed on them.

Legal Metrology Act 2009 and Rules mandate compulsory verification and stamping for weights and measures used in trade and commerce, which are apart from and additional to the calibration requirement under the GMP guidelines. A manufacturing site using weighing instruments in purchasing, manufacturing, and dispatch, but not having the Legal Metrology stamp on them, is in contravention of the law even if the weighing instruments have been calibrated under internal GMP programs. IMARC Engineering handles Legal Metrology mandatory verification as a part of the calibration process, where instruments requiring mandatory verification according to the state Weights and Measures law are identified, verification schedules are prepared, and Legal Metrology verification documentation is maintained to avoid Legal Metrology non-compliances resulting from the separate management of GMP and mandatory statutory calibration requirements.