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Project Service
Project Service
At Isha’s GMP Consultancy, we provide comprehensive solutions for setting up pharmaceutical manufacturing plants, ensuring seamless execution from concept to completion.
Scope of Services
Pharmaceutical Manufacturing Plant Setup
We offer complete solutions for the setup of:
- Formulations (Tablets, Capsules, Oral Liquids, External Preparations, Sterile Injectables)
- Active Pharmaceutical Ingredients (APIs)
- Excipients
Project Feasibility Studies
We conduct a thorough analysis to assess the feasibility of a proposed project, covering:
- Economic Feasibility
- Technical Feasibility
- Operational Feasibility
- Schedule Feasibility
Project Report Preparation
Our detailed project reports include:
- Building Construction Details
- Supporting Utilities
- Plant Equipment & Accessories
- Quality Control Instruments
- Technical & Financial Requirements
Site Master Plan Preparation
We design a comprehensive site master plan, including:
- Key & Site Plans
- Building Orientation
- Utility Block Placement
- Administrative Arrangements
Facility Designing
We provide detailed facility designs, including:
- Basic Technical Plan Layout
- Section & Elevation Drawings
- Area Table with Containment Details
- Nomenclature & Regulatory Approvals
Detailed Engineering Designing
Our engineering solutions cover:
- Basic Design
- Technical Datasheets
- Bill of Materials & Procurement List
Structural & Architectural Designing
We provide robust architectural and structural designs, including
- Soil Evaluation & Load Calculations
- Structural Detailing
- 3D Renderings for Interiors & Exteriors
- Aesthetic & Functional Elegance Management
User Requirement Specification (URS) Preparation
We develop URS documentation that includes:
- cGMP Standards Compliance
- Output & Load Calculations
- Automation & Cost Optimization
Vendor Optimization
We ensure vendor selection based on:
- Technical Capabilities & Timelines
- Delivery Schedules & Maintenance Support
- Quality vs. Cost Effectiveness
Project Execution & Management
We oversee the entire execution process, ensuring:
- Design Reviews & Phase-wise Completion
- Efficient Project Flow & Troubleshooting
- Streamlined Execution for Timely Completion
Commissioning & Validation
We ensure that all facilities meet the required standards through
- Facility Qualification
- Report Preparation & Review
- Final Inspection & Compliance Assurance
Technical Documentation & Regulatory Compliance
We assist with:
- Facility Proficiency Documentation
- Regulatory Filings & Compliance Reports
- Audit Readiness & GMP Consultancy (WHO-GMP, EU-GMP, USFDA Compliance)
With our expertise in project management and regulatory compliance, we help clients achieve operational excellence and regulatory approval seamlessly.