Скачать или смотреть Revised Schedule M Infrastructure Changes | Pharma GMP Compliance India

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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.

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