Key Considerations for a Successful Pharmaceutical Turnkey Project

Key_Considerations_For_Successful_Pharma_Turnkey_Project

In one of our earlier blogs, we discussed how turnkey pharmaceutical projects outperform multi-vendor projects. The blog explained how the turnkey approach is easier, more convenient, and more efficient to execute your pharma and bio-pharma endeavors.

Built on that understanding, it is equally important to gain nuanced insights into the key solutions that constitute a turnkey pharma project.
Fabtech’s start-to-finish turnkey solutions cater comprehensively to the needs of diverse pharma projects. In this blog, we highlight the important considerations we keep in mind during our three stages – Design | Build | Execute – which form the complete project life cycle.

10 Key Considerations for Making Your Successful Projects

1. Regulatory Compliance:

Pharmaceutical projects must adhere to strict regulatory requirements and guidelines. Fabtech ensures that all projects we design comply with local and international regulatory bodies, for pharmaceutical manufacturing, quality control, safety standards, and labeling requirements.

Our water for injection systems meet USFDA, WHO, and MHRA regulations, as well as ASME BPE, ISPE, and cGMP guidelines. Additionally, our cleanroom systems are certified as per BS 476 part b from DAC, with validation documents per NEBB guidelines and standards, making Fabtech the only Indian company with a 2-hour fire rating from Dubai Civil Defence.

2. Good Manufacturing Practices Guidelines for Pharmaceuticals (GMP):

GMP compliance is ingrained in our culture. Our equipment, processes, and solutions consistently meet GMP requirements, fulfilling quality assurance, personnel training, and facility design. For instance, our process equipment is cGMP and 21 CFR Part 11 compliant, ensuring that any data stored or exchanged electronically is secure, accurate, and reliable.

3. Design and Layout:

Efficient facility layout is crucial in optimizing workflow, minimizing contamination risks, and maximizing operational efficiency. Our experts meticulously plan the flow of personnel and materials, equipment placement, segregation of manufacturing areas, air handling systems, HVAC (heating, ventilation, and air conditioning), and other utility requirements. This ensures that the pharmaceutical manufacturing plant design and layout are utilized to their fullest potential.

The specific interlinking of operations, including the flow of personnel and materials, is particularly significant. We determine the sequence of handling material and the logical organization of personnel by clearly describing their functions and routes within the layout. The flow of material and personnel directly impacts GMP and the economic efficiency of an operation.

4. Equipment Selection:

Selecting the right equipment is crucial for the success of any pharmaceutical engineering project. As a pharma process equipment manufacturer, we begin by thoroughly understanding the project’s specific processes and product requirements. This detailed analysis allows us to identify the most suitable pharmaceutical equipment that can efficiently and effectively meet these needs.

Our experts also focus on reducing operational costs while maintaining operational excellence. The equipment selection is based on strategies that enhance productivity, precision, and scalability, giving the pharmaceutical manufacturing facility a competitive edge.

5. Supply Chain and Logistics:

The pharmaceutical supply chain can be complex and pose significant challenges. It demands adaptive solutions in diverse regions to maintain an uninterrupted flow in establishing pharma projects. Our turnkey approach fosters control and reduces timelines and delays, ensuring a smoother and enhanced execution.

Our robust inventory management leverages technological advancements such as Inventory Management Systems (IMS) or Enterprise Resource Planning (ERP) software. These tools help us predict demand more accurately. They also enable us to plan production schedules and inventory levels more effectively.

6. Quality Control and Testing:

We incorporate comprehensive quality control measures, including testing protocols, laboratory facilities, and equipment for thorough product analysis and release. Our pharma production processes ensure compliance with pharmacopeial standards, stability testing requirements, and other essential quality assurance procedures.

Before any equipment becomes operational, it undergoes a series of meticulous tests: – User Requirement Specification (URS), Design Qualification (DQ), Factory Acceptance Test (FAT) at the manufacturer’s site, Site Acceptance Test (SAT) at the user site, Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ). This stringent testing procedure ensures that all documentation is thoroughly reviewed and approved and that the equipment functions flawlessly, meeting its intended purpose at the customers’ plant.

7. Documentation and Record-Keeping:

Implementing comprehensive documentation systems is crucial for maintaining traceability, ensuring consistency, and facilitating regulatory inspections. Fabtech maintains elaborate document dossiers to record all aspects of the project, including DQ, FAT Protocols, IQ, and OQ to support validation.

Our User Requirement Specification (URS) document outlines general requirements and functional specifications along with organizational expectations from the equipment. URS also helps in the further stages of validation and building better-quality products to suit and meet the client’s needs.

8. Safety and Environmental Considerations:

We prioritize safety measures, including personnel safety, containment systems for hazardous materials, waste management protocols, and emergency response plans. We consciously adopt efficient engineering practices that benefit both healthcare and the environment.

We actively pursue environmental sustainability by leveraging energy-efficient equipment and practices that promote recyclability, thereby reducing our environmental footprint, such as sustainable features of HVAC Technology, PPGI cleanroom wall panels, Energy Recovery Wheel (ERW), Variable Pumping System, recycling E-waste.

9. Training and Workforce Development:

A well-developed training program for project staff ensures effective performance. Fabtech, as part of its complete start-to-finish cycle, offers training before qualification and provides infrastructure support for your application.

With the necessary skills and knowledge covering GMP principles, standard operating procedures (SOP), safety protocols, and quality control practices, obtaining EU GMP Certification for your facility becomes easier.

10. Project Management and Timelines:

A detailed project management plan defines the timelines, milestones, and deliverables. We leverage our digital platform – FabAssure to keep track of the project activities and manage projects and daily operations.

The system enables us to review the health of the project, the associated issues, and its delivery capability. It also allows an equal level of involvement of the third-party associates in cases where issues pertaining to them are highlighted, so as to avoid any last-minute rushes. Additionally, we have a separate team to manage customer expectations.

Incorporating these measures ensures the safety, efficiency, and high quality of pharmaceutical products, thereby minimizing risks in any pharmaceutical production. With over 2,000 turnkey pharmaceutical solutions completed worldwide and a team of 109 dedicated life engineers, our start–to–finish lifecycle follows a meticulously detailed route map.

Throughout the journey, we remain committed to creating the most value through our innovative pharma turnkey solutions. We offer flexibility, cost optimization, and adaptation to future needs.

Trusted by over 1,300 customers in 62 countries, we aim to make medicines affordable and accessible by enhancing pharmaceutical and healthcare capabilities.

From concept to completion, we build your next pharmaceutical, bio-pharmaceutical project with unparalleled expertise and dedication.
Contact Fabtech for expert support in designing and implementing your next turnkey pharmaceutical or bio-pharmaceutical project.