CMMS calibration management for Indian pharma plants under Revised Schedule M

The Ministry of Health and Family Welfare notified Revised Schedule M under the Drugs Rules, 1945, through G.S.R. 922(E) dated 28 December 2023. Its new title is "Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products".

Large manufacturers (turnover above ₹250 crore) were given six months to comply, and the Ministry of Health and Family Welfare states that it was implemented for them from 28 June 2024. Small and medium manufacturers (turnover up to ₹250 crore) were given twelve months.

A later amendment, G.S.R. 127(E) dated 11 February 2025, let small and medium manufacturers that filed an upgradation plan in Form A extend their timeline to 31 December 2025.

Later notifications or extensions may have been issued since. Confirm your own compliance status with CDSCO or your State Licensing Authority before relying on these dates.

Calibration appears in several clauses of Part I of Revised Schedule M. The main requirements are below, with the clause each one comes from.

If calibration records live in software, the computerised-system clauses of Part I also apply to that software.

Start with an instrument and equipment register. List every instrument and piece of equipment that measures, weighs, records or controls a GMP parameter, and for each one record its location, range, the tolerance it must meet, its calibration interval and the procedure that applies.

Then schedule calibration the way you schedule preventive maintenance: as recurring, due-dated work orders assigned to a named person or an approved external lab, with reminders before the due date.

The goal is to know, at any moment, which instruments are in service, due, overdue or out of service, and to be able to show that status to an inspector.

As-found and as-left are not terms used in Revised Schedule M. They are widely used calibration good practice that supports its record-keeping and investigation requirements.

As-found is the reading recorded before any adjustment. It shows whether the instrument was within tolerance while it was in use. As-left is the reading after adjustment, and it confirms the instrument is fit to return to service.

Recording both, together with the reference standard used, the technician and the date, gives QA what it needs if a result is ever questioned.

Out-of-tolerance handling is also good practice rather than a defined Schedule M term. When a calibration fails, take the instrument out of use, label it, and record the result.

Revised Schedule M’s section on active pharmaceutical ingredients (Part XII, 5.3) says instruments that do not meet calibration criteria are not used, and that deviations from approved calibration standards on critical instruments are investigated to determine their possible impact on product made since the last successful calibration. Applying the same discipline to every GMP instrument is good practice.

Link the finding to your deviation and CAPA process, and close it only when the instrument has been recalibrated or replaced and the impact assessment is complete.

For any instrument, an inspector may ask what its current calibration status is; when it was last calibrated, by whom and against which standard; and what happened when it failed.

A system that records every change with the previous value, the user and the time, and keeps a backup, makes those answers quick to produce. That is what Part I, 20.4 and 20.9 describe for computerised systems.

In a warning letter dated 3 March 2026, the US Food and Drug Administration (FDA) described its August 2025 inspection of Tentamus India Private Limited, a contract testing laboratory in Hyderabad. The FDA reported that its investigator found five blank preventive maintenance documents that had already been signed and dated 9 January 2025 in the "Performed by" section, and observed a lab manager signing and backdating spectrometry analysis reconciliation records. The FDA said this non-contemporaneous recording was a repeat observation.

The FDA asked for a corrective plan that ensures adherence to appropriate preventive maintenance schedules, and for records that are attributable, legible, complete, original, accurate and contemporaneous.

The letter applies US rules rather than Revised Schedule M, and it concerns a testing laboratory rather than a manufacturing plant. The lesson still carries over: a maintenance or calibration record only helps if the person who did the work completes it at the time the work is done. Revised Schedule M asks for records with dates and the identity of the people who did the work (Part I, 17.3.10.16) and a record of every data change (Part I, 20.4). The example comes from a public FDA document and is cited as a lesson in record-keeping, not as an Upvantix project.

Use this checklist when you assess a CMMS for calibration work. Clause references are to Revised Schedule M (G.S.R. 922(E)). Rows marked good practice go beyond the text of the rule.

Calibration sits alongside preventive maintenance, spare parts and maintenance KPIs in the same asset history. Reference standards and replacement instruments need the same stock control as other maintenance spares, and overdue calibrations and out-of-tolerance findings are signals worth tracking with the rest of your maintenance metrics.

Upvantix builds an AWS-native CMMS for plant and facility maintenance. It is a separate product from Upvantix Field Service Management (FSM). If you are preparing calibration records for Revised Schedule M, talk to us about your requirements and how they map to a CMMS.