Risk Assessment for New Facility

The facility subjected to risk analysis is the “Sterile Formulation Facility” at Dera Bassi, Punjab.

The facility design is carried out after a detailed conceptual design complying with Schedule M (Indian FDA), WHO (World Health Organization), USFDA, EU-GMP and other international regulatory agencies.

The building is designed in such a way that the warehouse, production, utilities, quality control, office area are properly segregated to prevent cross-contamination between these areas.

The facility shall have separate entry for manufacturing and packaging area.

Material flow shall be linear in the facility according to manufacturing process, which is sequentially as follows.

• Material receipt and storage
• Material dispensing
• Bulk manufacturing
• Product filtration
• Product filling & Sealing
• Lyophilization
• Automatic loading unloading
• Manual visual Inspection with space provision for Automatic Optical inspection.
• Secondary packaging
• Finished goods storage and dispatch
• Personnel entry is designed based on the cGMP requirement