Revised Schedule M Infrastructure Changes | Pharma GMP Compliance India скачать в хорошем качестве

Revised Schedule M Infrastructure Changes | Pharma GMP Compliance India

#RevisedScheduleM #PharmaInfrastructure #gmpcompliance Revised Schedule M Infrastructure Changes | Pharma GMP Compliance India Revised Schedule M has completely changed how pharmaceutical infrastructure compliance is evaluated in India. Earlier, many GMP gaps could be managed using SOPs and procedural controls. Today, infrastructure itself must prevent contamination, mix-ups, and errors. 00:00 – Why Revised Schedule M is a game changer 00:50 – What has really changed 01:45 – Facility layout & unidirectional flow expectations 03:15 – Physical segregation vs procedural segregation 04:12 – High-risk products: beta-lactams & hormones 05:05 – Dedicated weighing & dispensing areas 05:40 – HVAC as a core GMP system 06:35 – Area classification in non-sterile manufacturing 07:10 – Pressure differentials & visual indicators 07:55 – Temperature, RH & alarm-based monitoring 08:28 – Environmental monitoring infrastructure (EMS) 09:00 – Water system design & location risks 10:25 – Compressed air & critical utilities 11:00 – Equipment placement & cleanability 11:24 – Warehouse segregation & material status control 12:00 – Personnel flow, change rooms & gowning 12:29 – Waste flow & contamination risks 13:00 – Building finishes: epoxy, coving & flush fittings 13:38 – Maintenance access & technical corridors 14:10 – Final compliance message & upgrade strategy In this video, I explain only the infrastructure changes expected under Revised Schedule M, with clear, practical explanations covering: ✔ Facility layout & unidirectional flow ✔ Area segregation and zoning ✔ HVAC, pressure differentials & alarms ✔ Environmental monitoring systems ✔ Water systems, utilities & compressed air ✔ Warehousing, waste flow & personnel facilities ✔ Building finishes, maintenance access & engineering design This video is especially useful for: Pharma plant owners & promoters QA / Engineering / Projects teams Compliance heads preparing for inspections Companies upgrading plants before 31 December 2025 deadline ⚠️ Important: If your plant infrastructure is not aligned with Revised Schedule M expectations, SOPs alone will NOT protect you during inspections. If you found this video useful, 👍 Like | 💬 Comment | 🔔 Subscribe This helps the video reach more pharma professionals who genuinely need this information. If you found this video useful, please like, share, and subscribe for more pharma GMP and compliance insights. For consultancy, training, or gap assessments, feel free to connect. Linkedin: @mahealth-insights/ Facebook:@9733 Twitter: @9733 Blog: @ WhatsApp: https://whatsapp.com/channel/0029Vavm... #ScheduleM #RevisedScheduleMIndia #PharmaGMP #PharmaceuticalCompliance #PharmaInfrastructure #GMPIndia #CDSCO #DrugManufacturingIndia #PharmaEngineering #CleanroomDesign #PharmaQuality #GMPAudit #PharmaPlantUpgrade