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 VII
Quality Control
Quality Control Laboratory
Every manufacturing unit shall have a well-equipped Quality Control laboratory manned by qualified and experienced staff. The QC laboratory shall be independent of the production department. The QC department shall have adequate facilities for testing of starting materials, packaging materials, intermediates and finished products. Testing shall follow approved specifications and standard test procedures.
AI Explanation
Every factory needs its own QC lab with qualified staff. The QC lab must be completely independent from production. It must have all the equipment and resources needed for thorough testing.
QC Laboratory Equipment
The Quality Control laboratory shall be equipped with instruments necessary for performing the required tests. Equipment shall include but not be limited to: analytical balances, spectrophotometers (UV-Vis), dissolution apparatus, disintegration apparatus, HPLC system, and instruments for microbiological testing. All laboratory equipment shall be qualified and calibrated at defined intervals.
AI Explanation
Your QC lab needs specific instruments — balances, UV-Vis, dissolution testers, HPLC, microbiology equipment, etc. All must be qualified (IQ/OQ/PQ) and regularly calibrated.
Out-of-Specification (OOS) Results
Written procedures shall be established for handling Out-of-Specification results. The procedure shall include initial investigation by laboratory personnel, followed by a comprehensive investigation if the initial investigation fails to identify the cause. All OOS investigations shall be completed within 30 days of the OOS being identified. The batch shall not be released until the OOS investigation is satisfactorily completed.
AI Explanation
When test results are outside acceptable limits, you need a formal investigation process. Start with a lab check, then a full investigation if needed. Complete within 30 days. Don't release the batch until the issue is resolved.