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Pharma Turnkey Project 
  • Plan drawing as per required norms of WHO|GMP etc.
  • Project report including cost of total project, production capacity, operation cost, utility consumption etc.
  • Project management follow up & coordination with various agencies upto completion of total project.
  • Provide guidelines, effective supervision, site meetings and trouble shooting.
  • Selecting machines and equipment at economical cost.
  • Production documentation
  • Validation activity
  • Utility design
  • Manufacturing lic. for commercial production.
Turnkey Project
Plan Designing
  • Master plan designing
  • Architectural and structural drawing
  • Plan drawing for FDA passing
  • Drainage drawing
  • Detailed electrical drawing
  • HVAC system drawing
  • Water system drawing
  • Machinery placement drawing
  • utility drawing
  • Detailed designing for height, false ceiling, flooring, view panels etc.
  • Man-material flow diagram
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Project Management
  • Prepare pert chart in advance for each activity with time schedule.
  • To prepare plan as per required pharmaceutical norms, safety norms and proper utilization of land.
  • Prepare machinery layout as per process flow and easy operation.
  • Design utility system for easy supply and energy saving.
  • Design quality control, microbiological section and other required facilities as per need of company and drug rules.
  • Follow up & co-ordination with various agencies and contractors.
  • Provide guidelines to different agencies & supervision up to completion of total project.
  • Project items supply and deliveries schedule monitoring.
Project Report
PROJECT COST
  • Building cost-based drawing
  • Other infrastructure requirements with cost
  • Section wise machinery list as per required production capacity with cost
  • Utility requirements with cost
  • Quality control section requirements with cost.
  • All other requirements related plant with cost.
PROJECT DETAILS
  • Section wise production capacity
  • Energy consumption
  • Costing product
Detailed Engineering Design

DESIGNING OF PIPING WORK

  • Compress Air
  • Raw Water System
  • Purified water / WFI Loop system
  • Cooling water system
  • Chilled water system
  • Steam system
  • Stream System
  • Nitrogen System
  • Plumbing and drainage system
  • Material transfer system
  • Vacuum system
Detailed Engineering Design
Detailed Electrical Designing

HVAC SYSTEM

  • Clean room specifications
  • Identifying HVAC system based on requirement for different manufacturing function and facility area classification
  • Clean room
  • Contamination controls
  • Design and detail specification, BOQ & tender specification. Invitation of bids & recommendation of qualified contractor.
  • Checking & approval of vendor working drawings
  • Room wise lighting lay-outs.
  • Engineering of complete electrical distribution in the plant.
  • Prepare single line diagrams, power, earthling and lightning protection layout.
  • System requirements and schematic drawings for emergency power supply, UPS system & telephone and LAN system.
  • Cable tray lay-out.
Electrical Design
Plant Documentation & Quality Management System
System Development

Audit of all existing system starting from incoming material to dispatch and update it as per required norms.

Training
Validation

All types of validations like process validation, cleaning validation, analytical method validation, water system etc.

Documentation

Review and update SOP’s for all departments, site master file, master plans for validation and calibrations, quality control & production documents, stability study documents. Review and update all other required documents.

Dossiers & DMF Preparation
Planning