Turnkey project Services
Turnkey Project Services
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Turnkey Project Services refer to the comprehensive, end-to-end solutions provided by our company to design, build, and deliver a fully operational pharmaceutical manufacturing facility. These services cover everything from the initial concept to the final handover, including all necessary infrastructure, equipment, and systems. The goal is to ensure that the client receives a fully functional facility that meets all regulatory, safety, and quality requirements.
Here’s an overview of the core elements involved in pharmaceutical turnkey projects:
Project Planning & Feasibility Study
Needs Analysis: Understanding the specific requirements of the client, such as production capacity, product type (e.g., tablets, injectables), and regulatory standards.
Feasibility Study: Evaluating the technical, economic, and regulatory feasibility of the project to ensure its viability.
Site Selection & Assessment: Choosing the optimal location for the facility, considering factors such as local regulations, logistics, and environmental impact.
Design Engineering
Facility Design: Creating detailed architectural and engineering designs for the production plant, ensuring compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant industry standards.
Process Design: Developing the layout of the production lines, including workflows for manufacturing, packaging, and quality control. This also includes designing utilities and infrastructure such as HVAC systems, water for injection (WFI) systems, and power supply.
Cleanroom Design: Designing controlled environments (such as cleanrooms and aseptic zones) that meet stringent sterility and contamination control standards.
Construction & Installation
Construction: Managing the construction of the facility according to the approved designs. This includes civil, structural, and mechanical work, as well as installation of utilities like HVAC, water, and electrical systems.
Equipment Supply & Installation: Sourcing, supplying, and installing pharmaceutical manufacturing equipment, such as mixing tanks, filling lines, and tablet presses.
Validation & Commissioning: Ensuring that all systems and equipment are installed correctly and function according to design specifications. This includes Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
Regulatory Compliance & Licensing
Compliance with GMP & Regulatory Standards: Ensuring that the facility is designed and constructed to comply with local and international pharmaceutical manufacturing regulations, such as those set by the USFDA, EMA, TGA or WHO.
Documentation & Dossier Preparation: Assisting with the preparation of the necessary documentation for regulatory approvals, including facility qualification and validation records.
Training: Providing training to the client’s personnel on regulatory compliance, safety standards, and operating procedures.
Technology Transfer
Process Transfer: Moving the client’s product formulation and manufacturing processes from the laboratory or pilot scale to commercial-scale production.
Equipment Setup & Calibration: Ensuring that equipment is properly calibrated and operational to meet production requirements.
SOPs (Standard Operating Procedures): Developing and implementing SOPs for all stages of production, from raw material handling to final packaging.
Operational Support
Start-up & Ramp-up Support: Assisting with the initial start-up of the facility, ensuring that everything runs smoothly and ramping up to full production capacity.
Maintenance Services: Providing ongoing maintenance and troubleshooting support to ensure that the facility operates without interruption.
Post-commissioning Support: Offering additional support after the project’s completion, such as audits, upgrades, or process optimization.
Quality Assurance & Control Systems
Quality Systems Implementation: Establishing a robust Quality Management System (QMS) to ensure the highest standards of product quality and regulatory compliance.
Analytical Laboratories: Setting up laboratories for in-process quality testing, raw material testing, and finished product analysis.
Automation & IT Systems: Implementing automation technologies to streamline operations, reduce human error, and ensure traceability. This includes Enterprise Resource Planning (ERP) systems and Manufacturing Execution Systems (MES).
Turnkey Handover
Handover to Client: Providing the client with all necessary documentation, training, and operational systems. This includes final testing, validation reports, and operational guidelines.
Warranty & Aftercare: Offering warranties for both equipment and the facility itself, as well as long-term support services to ensure the facility continues to operate at peak efficiency.