Key Considerations for a Successful Pharmaceutical Turnkey Project

A pharmaceutical turnkey project succeeds when ten things are decided before construction starts.

Five are about the plant:

• the regulations it will be inspected under
• good manufacturing practice built into the design
• a layout that keeps people and materials apart
• the right equipment
• a reliable supply chain

Five are about running it:

• quality control and testing
• documentation
• safety and environment
• trained people
• a project management plan with milestones

Our pharmaceutical turnkey projects page explains what turnkey means and how Fabtech delivers it.

1. Regulatory Compliance

Pharma projects must follow strict rules and guidelines set by regulators. Fabtech makes sure that every project we design meets the rules of local and international regulators. These rules cover how medicines are made, quality control, safety standards and labels.

Water for injection is a highly purified grade of water. It is used to make injectable medicines. Our water for injection systems meet USFDA (United States), WHO and MHRA (United Kingdom) regulations. They also meet ASME BPE, ISPE and cGMP (current good manufacturing practice) guidelines.

The group's cleanroom systems are also certified as per BS 476 part b from DAC. They carry a 2-hour fire rating from Dubai Civil Defence. BS 476 is a British standard for fire tests. The validation documents for these systems follow NEBB guidelines and standards.

2. Good Manufacturing Practices Guidelines for Pharmaceuticals (GMP)

GMP means good manufacturing practice. These are the rules for making medicines safely and to the same quality every time. GMP compliance is part of how we work every day. Our equipment, processes and solutions consistently meet GMP requirements for quality assurance, personnel training and facility design. For example, our process equipment is cGMP and 21 CFR Part 11 compliant. 21 CFR Part 11 covers electronic records. This means any data the equipment stores or exchanges electronically is secure, accurate and reliable.

GMP compliant turnkey solutions in pharma work the same way. We design GMP facility turnkey solutions to the guideline from the first design review. Compliance is built in from the start and is never added later.

Read more: All about Good Manufacturing Practices (GMP) guidelines for Pharmaceuticals, Ensuring Quality in Manufacturing.

3. Design and Layout

An efficient plant layout is very important. It improves the flow of work, lowers the risk of contamination and helps the plant run efficiently. Our experts plan the flow of personnel and materials, equipment placement and the separation of manufacturing areas in detail. They also plan the air handling systems, HVAC (heating, ventilation, and air conditioning) and other utility requirements. This makes full use of the pharmaceutical manufacturing plant design and layout.

The way operations link to each other is especially important. This includes the flow of personnel and materials. We set the order in which material is handled and how staff are organized. To do this, we clearly describe the functions and routes of each within the layout. The flow of material and personnel directly affects GMP and the economic efficiency of an operation. Pharma facility design and turnkey solutions belong together because most of the later compliance cost is decided at the layout stage.

4. Equipment Selection

The right equipment is very important for the success of any pharmaceutical engineering project. Fabtech is a pharma process equipment manufacturer. We start by studying the project's specific processes and product needs in detail. This analysis shows us the most suitable pharma equipment to meet those needs efficiently and effectively. Our experts also work to reduce operating costs while keeping operations at a high standard.

We choose equipment that improves productivity, precision and scalability. Scalability means you can increase output later. This gives the pharmaceutical manufacturing facility an advantage over its competitors. You can see the ranges on our process equipment and water systems pages.

5. Supply Chain and Logistics

The pharma supply chain can be complex and hard to manage. Each region needs solutions that fit it, so that work on a pharma project does not stop. Our turnkey approach gives more control and reduces timelines and delays. This makes the project run more smoothly. Our reliable inventory management uses technology such as Inventory Management Systems (IMS) or Enterprise Resource Planning (ERP) software. These tools help us predict demand more accurately. They also help us plan production schedules and inventory levels more effectively.

6. Quality Control and Testing

We build full quality control measures into the plant. These include testing protocols, labs and equipment to test each product fully before it is released. Our pharma production processes comply with pharmacopeial standards. These are the official quality standards for medicines. The processes also meet stability testing requirements and other essential quality assurance procedures.

Before any equipment starts working, it goes through a series of careful tests:

This strict testing procedure makes sure that all documents are fully reviewed and approved. It also makes sure that the equipment works without faults and does its intended job at the customer's plant.

7. Documentation and Record-Keeping

Complete documentation systems are very important. They make every step traceable, keep work consistent and make regulatory inspections easier. Fabtech keeps detailed document files that record every part of the project. The files include DQ and FAT Protocols. They also include IQ and OQ. These documents support validation.

Our User Requirement Specification (URS) document describes the general requirements and functional specifications. It also sets out what the company expects from the equipment. The URS also helps in the later stages of validation. It helps build better-quality products that meet the client's needs.

8. Safety and Environmental Considerations

We give priority to safety measures. These include the safety of staff, containment systems for hazardous materials, waste management rules and emergency response plans. We choose efficient engineering practices that are good for both healthcare and the environment. We actively work to protect the environment. We use energy-efficient equipment and practices that make recycling easier. This reduces our impact on the environment. Examples include sustainable features of HVAC Technology, PPGI cleanroom wall panels, Energy Recovery Wheel (ERW), Variable Pumping System, recycling E-waste. PPGI means pre-painted galvanised iron.

9. Training and Workforce Development

A good training program makes sure project staff do their jobs well. As part of its complete start-to-finish cycle, Fabtech offers training before qualification. We also give infrastructure support for your application. The training covers GMP principles, standard operating procedures (SOP), safety protocols and quality control practices. These skills and this knowledge make it easier to get an EU GMP certificate for your facility from the competent authority. The competent authority is the national medicines regulator.

10. Project Management and Timelines

A detailed project management plan sets the timelines, milestones and deliverables. We use our digital platform, FabAssure, to track project activities and manage projects and daily operations. The system lets us review the overall status of the project, its issues and its ability to deliver. When an issue involves a third-party associate, the system gives that associate an equal level of involvement. This avoids last-minute rushes.

We also have a separate team to manage customer expectations. Without this kind of pharma turnkey project management, the other nine considerations are not put into practice.

Together, these measures make sure pharma products are safe, efficient and of high quality. They reduce risks in any pharma production.

Biopharmaceutical plants make medicines using living cells. Turnkey biopharmaceutical facilities differ from an oral solids plant (a plant that makes tablets and capsules) in three ways:

• The water and steam loads are larger. Cell culture, buffer preparation and cleaning use water for injection (WFI) in volumes a tablet plant never needs.
• Endotoxin control applies to every utility. Endotoxins are harmful substances that come from bacteria. So the WFI and pure steam systems are qualified as part of the process. They are not qualified as separate services.
• Single-use systems change the layout. These are bags, tubes and filters that are used once and then replaced. They mean fewer fixed vessels, more material movement and more storage for consumables.

Turnkey bioprocess facility design starts from the process flow and the batch schedule. The design then sizes the utilities and the rooms around them. Biopharma facility turnkey solutions that start from the building instead usually need a utilities upgrade later.

An injectable plant turnkey project has a different main challenge. The classified areas and the utilities must be qualified together. Classified areas are cleanrooms with a set limit on particles in the air. Sterile manufacturing facility design turnkey means the fill line, isolators, pass-throughs, WFI loop and pure steam supply are designed as one system. They are also proven as one system. An isolator is a sealed enclosure that keeps the product apart from the operator.

Turnkey solutions for sterile pharma facilities are judged on the day the media fills run. A media fill is a test run with a growth medium in place of the product. It proves that the filling process stays sterile. Only a single-contract partner can be held responsible for the result on that day. The Mechnikov vaccine facility in Nicaragua was delivered this way. The Sudair Pharma plant in Saudi Arabia is another Fabtech turnkey delivery. Both are on our projects page. Sudair is one of our Middle East projects.

The cost to set up a pharmaceutical manufacturing plant depends on five things. So the answer is a range, not one number. Any single number quoted before these five things are known is a guess.

A fixed-price turnkey contract gives one number once the issued-for-design package (the approved design documents) exists. Before that, ask for a budgetary estimate with the assumptions written down. A new site or an extension changes the order of the work more than the total cost. Our note on greenfield and brownfield projects explains how.

The ten considerations above describe what a good partner does. The questions below show whether the company you are talking to does them. The right column shows the answer a serious partner will give.

Fabtech has completed over 2,000 turnkey pharmaceutical solutions worldwide, with a team of 109 dedicated life engineers. Our start-to-finish lifecycle follows a very detailed plan. At every stage, we are committed to creating the most value through our innovative pharma turnkey solutions. We offer flexibility, cost optimization and plants that can adapt to future needs. Over 1,300 customers in 62 countries trust us. We aim to make medicines affordable and accessible by building pharma and healthcare capabilities.

We build your next pharmaceutical or bio-pharmaceutical project from concept to completion, with the same care on every site. Contact Fabtech for expert support in designing and implementing your next turnkey pharmaceutical or bio-pharmaceutical project. We expect to be asked the questions above. Our pharmaceutical turnkey projects page shows how we answer them.