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 VI
Production and Process Controls
Production Planning
Production operations shall follow clearly defined procedures in accordance with manufacturing and marketing authorizations, with the objective of obtaining products of the requisite quality. All handling of materials and products shall be done in accordance with written procedures. Material dispensing, processing, in-process controls, sampling and labelling shall be performed and recorded.
AI Explanation
Manufacturing must follow clear written procedures that match your license. Every step — weighing, mixing, testing, labelling — must be done per procedure and documented.
Process Validation
Process validation shall be conducted for all manufacturing processes to demonstrate that the process is capable of consistently delivering quality product. Validation studies shall be conducted in accordance with defined protocols. Three consecutive successful production batches shall be completed as part of the validation exercise. Revalidation shall be carried out whenever there is a change in equipment, formulation, process or batch size that may affect product quality.
AI Explanation
You must prove your manufacturing process works consistently by running three successful batches under the validation protocol. Redo validation when you change equipment, formulas, processes, or batch sizes.
Prevention of Cross-Contamination
Contamination of a starting material or product by another material or product shall be avoided. This risk of accidental cross-contamination arises from the uncontrolled release of dust, gases, particles, vapours, or organisms from materials and products in process, from residues on equipment, and from mixing up of materials. Special attention shall be given to highly sensitizing materials, biological preparations, hormones, cytotoxic substances, and other highly active pharmaceutical ingredients.
AI Explanation
Prevent any product from being contaminated by another product. This can happen through dust, residues on equipment, or mix-ups. Be extra careful with potent drugs like hormones, biologics, and cytotoxic substances.