Services for Turnkey Projects
We offer the Design Engineering, Project Management, Construction Management packages in totality or individually as per the specific requirements of our valued Clients.
This is broadly divided into following services:
- Design and execution:-
- Civil & Structural
- Clean Rooms
- Process Equipment’s
- Process Piping
- Utility Piping
- Fire system
- SS equipment’s and accessories.
PHARMADEEP Turnkey can provide its customers with a complete feasibility study comprising of:
- Market Study
- Technical Study
- Financial Study
The studies conducted will rely on both primary and secondary data, which will involves both desk and field works. Accordingly, the typical approach employed for such studies includes followings:
- Key Project Goals
- Personnel Requirement
- Licensing and Regulatory Requirements
- Production Capacity
- Production Budget
- Total Investment Cost
- Annual Income Forecast
- Annual Cost of Production
- Net Surplus
- Business Valuation
- Income Statement
The Detailed Feasibility Report will help you to arrive at a well thought, techno commercial decision to proceed with most viable project plan.
A Master Plan, also called a comprehensive plan, provides a long-term vision for the built environment of a Pharmaceuticals Factories and Laboratories. It guides the appropriate use of lands in order to Plan and envisage future growth potential. As a result, the Master Plan has a direct relationship to the growth of organization.
PHARMADEEP Turnkey has an Expert team of Architects and Designers to Make Futuristic Master Plan to identify:
- Suitable locations for Manufacturing, Administration Research & Development and Utilities.
- Green Belt and Environment management.
- Opportunities to extend and/or improve open space, recreational areas, and civic facilities;
- Strategies for Future development
Why should a Master Plan be important to you?
The simple answer is that a Master Plan is important because it affects Future growth plan.
- Master Plan helps to adopt new manufacturing technologies.
- Pharmaceuticals Manufacturing is very dynamic and the master plan helps you to device compliance with future GMP Standards.
- Master plan helps you to adopt new automation.
It is a method for determining what features a Pharmaceuticals Plants should have, and what metrics can be used to measure the quality or performance of the Pharmaceuticals Plants, based on analysis of Clients needs and preferences. The concept engineering process generally includes framing the project, collecting data, analyzing the data, and selecting actions.
Concept Engineering will be a crucial document to decide the project plan and will be a base document for Detailed Engineering. This involves the initial conceptualization of the entire project which helps in forming the foundations on which the rest of the project is built up.
The Concept Engineering will define followings:
- Plant Design Concept with respect to various International GMP guidelines like EU GMP, PIC/S, US FDA and WHO.
- Interface with International Process/ Regulatory Authorities.
- Man and Material Movements.
- Logical Flow for the material and man movement.
- Utilities and Equipments Balancing.
- Time and Cost estimates.
Concept Engineering will have following stages:
This involves gathering functional requirements of the proposed facility which includes production process together with the required level of automation
- Dosage forms
- Batch sizes
- Containment needs
- Type of equipment and machinery
- Inventory norms
- Expansion philosophy
Starts by addressing the following concerns:
- Preliminary layout based on availability of space and resources
- Targeted environmental cleanliness category
- Optimal water quality and water treatment facilities
All the above data are finally used to prepare the following:
An overall budget for project execution The entire facility layout for the preliminary stage as per national and international regulatory norms
- Conceptualization of building construction
- Drawing out user requirement specification (URS)
- Drawing out project schedules through bar charts
- Water generation and distribution system design
- Production environment designing like heating, ventilation and air conditioning
- Pressure differential monitoring
During BASIC ENGINEERING, the following definitions of the Project will be developed:
- Alternative Plant Layouts meeting GMP requirements
- Men/material flow drawings on the approved layout
- Design of Heating, Ventilation, Air Conditioning and Pressure Differential system with proposed Air Flow Diagram
- Design on treatment, purification, filtration and distribution of various utility systems like Water, Steam, and Compressed Air etc.
- Estimate requirements of various utilities
- Develop P&IDs for Process and Utilities
- Estimate Electric Power requirements for the plant and suggest High Tension and Low Tension Distribution schemes
Detailed Engineering is the essential bridge between the basic engineering and construction phase of a project. It is “Converting Thoughts into reality”.
We provide detailed engineering services for a project as follows:
- Process Engineering including selection of the right equipment
- Electrical Engineering
- Building Management and Automation Systems
- Preparation of detailed specifications, data sheets and Bill of Quantities for various plants, equipment, machinery and system
- Supply of various plant equipment, machinery and systems
Activities involved in Detailed Engineering
- Plot Layout
- Area Layout
- Men / Material Movement…etc.
- Industrial Drainage
- Domestic Drainage …etc.
- Soil Drainage …etc.
- Illumination Design
- Lighting Layout …etc.
- Electrical Load Data
- Electrical Layouts
- Cabling Details
- Bill Of Quantities (BOQ) …etc.
- HVAC Design
- Air Handling Unit (AHU) Locations
- Air Flow Diagrams
- Ducting Layouts
- Purified Water Generation System
- Water for Injection (WFI)
- Compressed Air
- Pure Steam
- Plant Steam
Project management in our field of operations consists of the application of knowledge, abilities, tools and techniques enable us to complete project activities in order to satisfy customer requirements and thus accomplish the final goal with efficacy and efficiency.
The Project management functions include:
- Project Structure
- Project Scheduling and Monitoring
- Propose cost and safety measures during detailed engineering
- Technical assistance in getting statutory approvals
- Checking availability of design information
- Detailed Project Review
- Propose cost and safety measures during detailed engineering
- Conduct periodic co-ordination meetings with Client to review actual progress of work as against planned work schedule and remove bottlenecks
- Carrying out mechanical installations, commissioning and validation
Our Project Management team is geared up to monitor every individual project with following key areas:
- Project Scope Management
- Project Integration Management
- Project Time Management
- Project Communication Management
- Project Risk Management
- Project Procurement Management.
- Project Human Resources Management.
- Project Cost Management.
- Project Quality Management.
Commissioning Validation includes the following:
- Generation of User requirement sheets.
- Design Qualification
- FAT ( Factory Acceptance Test)
- Installation Qualification
- SAT ( Site Acceptance Test)
- Operation Qualification
- Performance Qualification.
- VMP ( Validation Master Plan)
- SMF ( Site Master file )
- GMP Auditing and Gap Analysis.
- Protocol Development & execution
- Standard Operating Procedures ( SOP )
Regulatory Compliance Support
- cGMP (current Good Manufacturing Practice) compliance
- Advisory services to queries pertaining to Pharma GMP, GLP, QA and regulatory affairs
- Compliance audits as per current and updated statutory Pharma regulations
- GAP Analysis/Due diligence
- Schedule ‘M’ Requirements & documentation for compliance to Indian FDA’s norms
- Site Master file as per PIC/s & Local FDA requirement
- Quantitative Risk Assessment ( QRA)
- Environment Impact Assessment ( EIA)
- Safety Audits.
- Energy Audits
- MP and Compliance.
- MP Auditor Training for Quality Systems.
- MP requirement for pharmaceutical facilities.
- MP requirements for the Warehouse, Utilities & Quality control.
- harmaceuticals Documentation for compliance with GMP
- riting effective SOPs in a GMP Environment.
- harmaceuticals Manufacturing Support.
- pgrading the GMP standards of the existing plant, without much of additional investment.
- ow to conduct Internal Audits
- How to conduct on the Job Trainings.
- Training of Trainers.
- Evaluation of supervisory staff and managers after training.
- Standard Operating Procedures – QA/QC/Manufacturing/Maintenance
- On the job Training for QA/QC/Shop floor employees
- Process Validation
- Installation Qualification
- Operational Qualification Method Validation
- Facility Qualification
- Purified Water validation
- Current Good Manufacturing Practices
- Transferring Skill on Validation
- Clean Room Operations, Equipment Handling and Documentation Activities
- Personal Behavior in Clean areas
- Calibration Procedures and Maintaining Records
- WHO guidelines
- COST Improvement Projects
- Technology Transfer
- Training modules as per the customer specific requirements ….in RA, QA, cGMP, GLP, GCP, ISO, 21 CFR parts, Audits, Validations and many more topics.