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 IX
Personnel and Training
Personnel Qualifications
There shall be an adequate number of personnel with the necessary qualifications and practical experience. Key personnel shall include the head of production and head of quality control who shall be independent to each other and shall have the requisite qualifications and experience as specified. The responsibilities of key personnel shall be clearly defined in writing.
AI Explanation
You need enough qualified people. The production head and QC head must be different people (independent) with proper qualifications. Everyone's responsibilities must be clearly written down.
Training Program
All personnel shall be trained in GMP requirements relevant to their duties. Training shall be conducted by qualified individuals. Initial and continuing training shall be provided. Effectiveness of training shall be assessed periodically. Training records shall be maintained for each employee including: topic, date, trainer name, and assessment results. Personnel working in areas where contamination is a hazard shall receive additional specialized training.
AI Explanation
Everyone needs GMP training relevant to their job. Check if training actually works, and keep detailed records (topic, date, trainer, results). People in sensitive areas need extra specialized training.
Quality Assurance Responsibility
The Quality Assurance function shall be independent of production. The head of QA shall have the authority to approve or reject any material, intermediate or finished product. QA shall be responsible for reviewing all production records, investigating deviations, approving SOPs, conducting stability studies and overseeing the self-inspection programme. The QA department shall not delegate its core responsibilities to production or any other department.
AI Explanation
QA must be completely independent — not under production's control. The QA head has the authority to approve or reject products. QA reviews all records, and this authority cannot be delegated to other departments.