Building a drug manufacturing plant the turnkey way

Setting up a drug manufacturing plant is no piece of cake, especially in today’s highly complex and dynamic biopharma landscape. Regulatory expectations differ across geographies and with time. Enhancing operational efficiency is of utmost importance to ensure profitability. Pressure to get to market before your competitors is higher than ever before. And sustainability in terms of environmental, social and governance aspects is not negotiable. If you want to set up an effective and sustainable drug manufacturing plant, you have to address all of these concerns simultaneously.

In our experience as engineering, procurement, and construction (EPC) partners, we’ve seen one blind spot come in the way of the timely and effective completion of many construction and expansion projects. That blind spot is the lack of integration upfront, at the start of the planning stage itself.

When setting up a drug manufacturing plant, the most important thing for you to understand is that it’s not just a civil construction project; it is a dance between many diverse elements that come together to create a harmonious system. Setting up a drug manufacturing plant calls for the seamless integration of every part of the project, from process design and utilities to automation, documentation and regulatory compliance. Depending on where in the world your project is located and which markets you sell to, you may have to comply with US FDA, cGMP, UK MHRA, EMA and/or other relevant regulatory frameworks.

This is, in our experience, one of the biggest challenges in setting up a drug manufacturing plant: anticipating operational as well as compliance needs before any large capital investment is made.

The right time to consider every element of your drug manufacturing plant (and how it will integrate with all the other parts) is before you begin to build even one room of your project. If you delay the process of integration planning, you risk project fragmentation, inconsistent quality, incompatibilities between systems, and costly rework.

If you’re planning on how to set up a drug manufacturing plant and you’re struggling with integrating the myriad elements involved: we see you. And we can’t recommend a turnkey solution enough.

Whether you’re a new pharma manufacturer, an existing biopharma company looking to expand capacity or diversify your product line, or a contract development and manufacturing organisation (CDMO), we highly recommend approaching a turnkey partner to help you set up a drug manufacturing plant. Partnering up with a turnkey solutions partner is one of the best ways to ensure compliance, speed and reliability for your pharma plant in the long run.

Biopharma turnkey solutions partners do the highly valuable work of end-to-end project execution. Right from the planning and design stages to engineering, installation and validation, they do everything so that you can receive a ready-to-operate drug manufacturing facility.

Be it quick setup, more seamless compliance or lower risk, turnkey partners do everything that moves the needle when it comes to launching biopharma production smoothly, efficiently, and cost-effectively.

 

So, what are turnkey pharma factory solutions?

Turnkey pharma factory solutions are technical and project management services in which a single partner manages the entire lifecycle of your drug manufacturing plant project. Right from concept and design to construction and commissioning.

Name a part of the drug manufacturing plant setup process and a good EPC or turnkey partner should be able to support you through it. Feasibility studies, concept design, layout, engineering, equipment sourcing, utility mapping, HVAC planning and installation, cleanroom design and build, installation, documentation, commissioning… there’s not much that’s outside the purview of a good turnkey pharma solutions provider.

In essence, working with a turnkey solutions partner to set up or expand your drug manufacturing plant is one of the best decisions you can make from a risk minimisation, cost optimisation, and quality enhancement perspective.

 

Why you need to set up a drug manufacturing plant the turnkey way

Pharmaceutical manufacturing is among the most regulated industries across the world. Any lapse in compliance is not just a time or cost issue, but also a trust issue.

It is undeniable that setting up a drug manufacturing plant is complex, time-sensitive, and expensive. Beyond regulatory hurdles, you’ll be running from pillar to post trying to manage lengthy project timelines, large infrastructure budgets, coordination and communication between contractors, potential design gaps or errors, and/or compatibility between systems.

So, what does a turnkey solution do for you? In short, it de-risks your timelines and budgets.

Turnkey solutions change the game. For instance, in our turnkey offerings, we at PodTech™ embed efficiency and compliance into project planning right from the outset. In every phase of the project, we ensure process optimisation and adherence with regulatory requirements. This means that the final product is not simply compliant but more than adequately designed for high-performance operation.

We engineer quality into your drug manufacturing plant right from the start rather than retrofitting it after construction. This means that we anticipate and address process variability right from the start. We embed controls and safeguards proactively. And we build a drug manufacturing plant that delivers the results you want, all while leaving scope for you to scale or adapt your operations as needed in the future.

Whether it comes to cleanroom design, optimising layout for your drug manufacturing process steps, integrating HVAC systems, or any other aspect of a pharma facility, you can expect a lot more from turnkey partners like us than from a motley collection of specialists and suppliers.

That’s why we’re such strong advocates of turnkey solutions: because of the quality, consistency, compliance and quality that you can expect from turnkey EPC partners like us.

 

In part two of this blog post, we’re going to address the specifics of what you can expect from a turnkey solution and your turnkey partner in your journey of setting up a drug manufacturing plant. From customisation and compliance to safety and sustainability, there’s no stone EPC partners like us leave unturned in the turkey solutions we offer. Stay tuned to understand how that can help you set up your pharma manufacturing operations.

As you’re setting up a drug manufacturing plant, what can you expect from a turnkey solutions partner that would be harder to expect from a fragmented collection of vendors and experts? Let’s get into the details.

 

Setting up a drug manufacturing plant the turnkey way: What to expect

In terms of process, you can expect fewer risks and increased predictability. This is a consequence of fewer delays, lower chances of miscommunication, a pre-planned and well-controlled budget, and more efficient documentation and compliance protocols.

In terms of product, you can expect to receive a fully functional, GMP-compliant, and validated drug manufacturing plant that is ready for operations from day one; “plug and play”, as we like to call it.

Let’s look at what setting up a drug manufacturing plant the turnkey way really involves:

Custom-built solutions are necessary for many drug manufacturing process steps today. Having a turnkey partner helps you build that customised solution, tailored to your specific business and process needs.

Having a turnkey solutions partner is a superior option compared to spending your capital on off-the-shelf solutions because a turnkey partner builds for you. They analyse your market goals, target export markets, budget, desired production capacity, dosage forms, and also future plans for expansion, new products, and/or different processes. This means that opting for a turnkey solution, especially one designed keeping in mind future flexibility, is best suited to your long-term vision.

Shorter project timelines, which translate to reduced time-to-market, become possible due to faster decision-making, teams working parallely instead of sequentially, fewer vendor delays, and better communication leading to fewer redesigns, redundancies, or unnecessary duplications. WIth a turnkey partner, you’re likely to see 30 to 40% faster project completion and delivery.

When setting up a drug manufacturing plant with the help of a turnkey solutions partner, you also enjoy the benefits that come from single-point responsibility. You don’t have to communicate or coordinate with dozens of different vendors because your turnkey partner will manage engineers, designers, architects, contractors, OEM suppliers, validation teams and documentation experts.

Having a single point of contact and responsibility gives you the luxury of smooth communication paired with seamless execution. Moreover, you also get the added bonus of access to specialised expertise in pharma engineering, utility engineering, HVAC, cleanroom design, process flow, equipment selection and more without having to develop all of those relationships by yourself. That’s an unparalleled advantage that most drug manufacturers don’t consider while setting up their plants.

Ensuring complete regulatory compliance with WHO GMP, US FDA, MHRA, and/or any other relevant authority is a whole project in itself. Partnering up with a turnkey solutions provider means handing over the responsibility for this project to them. They take care of cleanroom classification, HEPA filtration and HVAC design, GMP-compliant layout design, equipment qualification including installation, operational and performance qualification (IQ, OQ, and PQ), and validation.

For instance, we at PodTech™, offer end-to-end documentation support as it is the cornerstone of regulatory compliance. From IQ, OQ and PQ documentation to factory acceptance testing (FAT), equipment manuals, SOPs for operations, and validation protocols, we provide everything you need documentation-wise to reduce your internal burden and prepare your facility and staff for audits.

Another often overlooked perk of working with a turnkey partner for your drug manufacturing plant is better budget control. The strategic planning that turnkey partners do prior to executing your project can give you a fixed-budget plan, meaning you avoid having to shell out more money later on on costs you hadn’t anticipated yourself. Overall, when working with a turnkey partner, you enjoy cost savings by minimising delays from contract coordination, rework due to design errors, inefficient material usage, and overspending on equipment.

Better quality assurance is one of the by-products of having your entire project being managed by a single expert team. Be it civil work or electrical utilities, mechanical installation, cleanroom setup, equipment installation or validation, your turnkey partner eliminates the perils of mismatched workmanship and improves overall project quality.

Sustainability is an important consideration for any business operating in today’s world, and more so for a business in the pharma manufacturing space. Which is why turnkey partners play such a crucial role in helping you set up a drug manufacturing plant – they embed sustainability and safety into the very DNA of your project design. The best turnkey partners can optimise airflow, make your HVAC systems more energy efficient, design effective waste management systems, and help you achieve water neutrality. In short, they can help you achieve long-term sustainability.

 

Steps involved in setting up a drug manufacturing plant the turnkey way

Now, the most important part. What are the actual steps involved in setting up a drug manufacturing plant with a turnkey solutions provider?

1. Strategic planning and feasibility analysis, because proper planning is the first step in setting up a sustainable drug manufacturing plant. Ideally, your turnkey partner should begin with defining the project scope, conducting detailed feasibility studies, and aligning financial, technical and regulatory goals. You can only set up a compliant and realistic, yet future-ready plant if you’ve planned ahead, including strategic site selection, risk assessment, cost-benefit analysis, GMP- and ISO-compliant layout design, resource allocation, and efficient project scheduling.
2. The initial feasibility analysis and comprehensive planning steps are followed by the plant design and layout processes. This is a critical step as it lays the ground for compliance with WHO GMP, US FDA regulations, and any other relevant standards you need to comply with. Moreover, these processes help you optimise workflow and safety by efficiently separating non-clean and clean areas. It allows you to ensure efficient material and personnel flow, air pressure differentials, and controlled HVAC to prevent contamination, enhance productivity, and reduce wastage. Design and layout planning also helps you to appropriately integrate utilities like compressed air, purified water, water for injection (WFI), and clean steam. Put together, all of this contributes to seamless compliance.
3. Engineering, procurement and construction, or EPC, execution comes after design and layout approval. This stage involves procuring process equipment and utilities, installing civil, electrical and mechanical systems and constructing cleanrooms and other controlled areas, all under supervision to ensure timelines, quality and safety are not compromised.
4. Then comes equipment installation and validation. Once a machine is installed, your turnkey partner must conduct rigorous validation before you can begin operations. This includes IQ, OQ and PQ. IQ, or installation qualification, ensures that the equipment is installed correctly. OQ, or operational qualification verifies that systems are performing as expected. PQ, or performance qualification, ensures that the process delivers high quality results consistently. These processes also include preparing detailed validation documentation for audits.
5. Next, your turnkey partner will help you with regulatory documentation and approvals. This includes whichever regulations are applicable to your processes and region of operation. Think WHO GMP certification documentation, risk assessments, SOP preparation, quality manuals, and validation protocols. This stage will undoubtedly help you appreciate what turnkey partners like us bring to the table – our regulatory insight enables smoother approval processes and consequently, faster market entry.
6. You may have a ready-to-operate drug manufacturing plant from day one, but your personnel must also be prepared for operations. A good turnkey operator provides support beyond construction and installation; they also support personnel training. Ideally, they provide on-site training to equipment operators and quality teams so that everyone working in your drug manufacturing facility has the requisite knowledge of systems and processes.
7. Setting up a turnkey drug manufacturing plant is a complex endeavour, but the task doesn’t end there. Post-construction maintenance, repairs and continuous improvement are just as important. So, you should choose a turkey solutions provider who sees themselves as not just a vendor, but a partner in the truest essence of the word. The right turnkey partner will offer ongoing technical and compliance support; think revalidation, audits, preventative maintenance, expansions, new dosage forms, and the like. All these activities ensure that your drug manufacturing plant stays compliant with relevant norms.

 

At the end of the day, the right turnkey partner is someone with whom you build a long-term relationship built on competence, trust and communication. Setting up a drug manufacturing plant is no easy feat, but the right partner will provide the necessary support and more to guide you through the entire planning, execution and operational phase.

If you’re looking for a turnkey partner to set up a drug manufacturing plant for you, reach out to our expert team at PodTech™ today.