What is the Lux requirement for Sodium vapour light in manufacturing area?
Please refer CDSCO self assessment GMP checklist Point no. 15.7 stating the lux level requirement in API.
Production Area 400 to 500 Lux, Visual Inspection area - 500 to 600 Lux & Other area - 200 to 400 Lux.
Refer; CDSCO Home page - Notification/Circulars/Publications - (Checklist -Public Notice regarding Self assessment tools for drug regulator/stakeholders for Good Manufacturing Practices (GMP)/Good Laboratory Practices (GLP) and other documents)
Dear thanks for immediate reply…but i m asking for sodium vapour lamp which is used in product like Fexofenadine etc.
Dear, as per CDSCO Lux requirement, provide Schedule M as a reference.
But in sch-M No one such limit given.
Can any one provide reference documents for this Lux level limit in pharmaceutical sector ???
Very true but checklist is all a standard and we have to comply it.