Isha's GMP Consultancy, Chennai - 600 014, India Monday - Saturday 08:00-19:00 +91 9976491578

Turnkey Projects

We Provide Complete solution to Pharmaceutical Manufacturing plant set-up for:
  • Formulations (Tablets, Capsules, Oral Liquid, External Preparations, Sterile Injectables)
  • APIs
  • Excipients

PROJECT FEASIBILITY STUDIES

We carry out analysis of a proposed project to determine whether it is feasible or not.
  • Feasibility Studies will include:
  • Economic Feasibility
  • Technical Feasibility
  • Operational Feasibility
  • Schedule Feasibility

PROJECT REPORT PREPARATION

Comprises of:
  • Building construction details
  • Supporting utilities details
  • Plant equipment details
  • Quality control instruments details
  • Plant accessories details
  • Technical requirement details
  • Financial details

SITE MASTER PLAN PREPARATION

Comprises of:
  • Key Plan
  • Site Plan
  • Building Orientation
  • Utility Block Placement
  • Administrative Arrangements

FACILITY DESIGNING

Comprises of:
  • Basic Technical Plan Layout
  • Section and Elevation Drawings
  • Area Table with detailed Containment
  • Nomenclature with necessary approval

DETAILED ENGINEERING DESIGNING

Comprises of:
  • Basic Design
  • Technical Datasheet
  • Bought Out Quantity list

STRUCTURAL & ARCHITECTURAL DESIGNING

Comprises of:
  • Soil Evaluation
  • Load Requirements
  • Structural details
  • Load Bearing Calculations
  • Interior and Exterior 3D imposements
  • Overall Elegance Management

URS PREPARATION

Comprises of:
  • Required Standards of cGMP
  • Output requirements
  • Load Calculation
  • Automation requirements
  • Cost Effectiveness

VENDOR OPTIMIZATION

Comprises of:
  • Vendor assessment with respect to technical capabilities, timelines, delivery schedules, maintenance, etc.
  • URS compatibility
  • Dynamic balance between quality and economy

PROJECT EXECUTION & MANAGEMENT

Comprises of:
  • Project review based on design drawings
  • Phase wise target completion
  • Project flow direction
  • Troubleshooting and streamline execution

COMMISSIONING

Comprises of:
  • Facility Qualification
  • Report preparation and review
  • Finishing and elegance

TECHNICAL DOCUMENTATION

Comprises of:
  • Facility Proficiency Portfolio
  • Regulatory Documentation
  • Audit Compliance Compatibility
  • WHO GMP consultancy
  • EU GMP /USFDA Consultant