Schedule M Browser
Browse the full text of the Revised Schedule M (2025). We've organized the gazette notification into an indexed, searchable structure complete with plain English explanations for complex requirements.
Part III
Equipment
Equipment Design and Installation
Equipment shall be designed, constructed, adapted, located and maintained to suit the operations to be carried out. The equipment shall be designed so as to minimize any risk of error and to permit effective cleaning and maintenance. Equipment surfaces coming into contact with any product component shall not be reactive, additive or absorptive to an extent that would alter the quality of the product.
AI Explanation
All equipment must be fit for purpose, easy to clean, and not contaminate your products. Contact surfaces must not react with or absorb the product.
Equipment Qualification
All equipment shall be subjected to qualification protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Qualification shall be completed before equipment is used in routine manufacturing. Re-qualification shall be performed at defined intervals and after any significant change or modification.
AI Explanation
Before using any equipment, you must prove it's installed correctly (IQ), works as intended (OQ), and performs consistently in real conditions (PQ). Redo this periodically and after major changes.
Equipment Calibration
Measuring, weighing, recording and control equipment shall be calibrated and checked at defined intervals using certified reference standards. Calibration records shall be maintained. Equipment that does not meet calibration criteria shall be clearly marked as such and shall not be used until it has been recalibrated.
AI Explanation
Scales, thermometers, gauges — anything that measures must be regularly calibrated against known standards. If calibration fails, label the equipment and don't use it until fixed.