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Complete lifecycle service

Our team of pharmaceutical and biotech specialists brings together the expertise, innovation, industry knowledge and commercial awareness to serve the pharma industry. We bring a flexible and customised approach to problem solving that understands the complexities of producing pharmaceuticals within a highly regulated environment.
 
We deliver a full range of services from consultancy to the design, engineering, procurement, construction management, validation and start-up of pharma facilities worldwide.

Our ability to service the needs of our clients comes from our culture, which is focused on process-driven facilities. Our engineers, architects and designers are experienced in a wide range of processing technologies. Our process engineers, working closely with our facility design, process automation, piping design, pharmaceutical systems and validation groups, efficiently translate our clients’ needs into an optimum manufacturing process and facility design in compliance with all applicable cGMPs, codes, regulations and standards. We provide sound, cost-conscious engineered solutions for our clients’ processing and manufacturing needs.

From the original idea stage, we will help define our clients’ business case, evaluate and mitigate risks, challenge current standards and thinking and develop the right solution. And through the investment life cycle, we will support our clients from initial feasibility and investment advice, to development, project management, execution, validation, start-up and on-going asset support.

<p>Getting the right start is crucial to maximising the benefits from our clients’ planned investments. That’s why clients come to us, because they know we have a commitment to quality and to understanding their business objectives (such as time-to-market and cost effectiveness), so that we can help them find the right solution. We and our clients like to work from the earliest phases of their planned investments, in a collaborative team-focused way, so that we can help to give their project the right start, applying all of our experience, expertise, creativity and innovation.</p><p>Our skills include:</p><ul><li style="">Simulation</li><li style="">Process architecture</li><li style="">Process flow diagrams</li><li style="">Facility programming</li><li style="">Utility / sustainability analysis</li><li style="">Energy modelling</li><li style="">Feasibility studies</li><li style="">Conceptual design development</li><li style="">Preliminary investment cost estimate</li><li style="">Preliminary integrated master schedule</li><li style="">Funding document preparation</li></ul>

<p style="">As new pharmaceutical sites are developing in emerging markets such as the Middle-East, China, India, Brazil and Russia, existing facilities are being relocated, rationalised or even closed. Clients reassessing their existing assets with a view to increasing operational effectiveness, or planning a new build, often look to Amec Foster Wheeler to develop a strategic site plan, also known as a site master plan. We provide a high quality service to assist our clients with site selection and site master planning, adopting a holistic approach using our well-proven methodology. </p><p>We consider a wide range of factors including:</p><ul><li style="">Governing authority factors: planning authorities, local government, local community, economic incentives</li><li style="">Environmental concerns: air quality, water usage and quality, site drainage and detention factors as well as the impact on local and regional natural resources</li><li style="">Site location: land cost, supporting infrastructure, natural hazards, accessibility, local workforce, planning regulations</li><li style="">Site infrastructure: utilities availability, waste handling, emergency back-up</li><li style="">Buildings: planning and zoning codes, footprint, topography and soil conditions, sustainability requirements<br style="" /><br style="" /></li></ul>

<p style="">We apply our in-depth knowledge of applicable legislation around the world to deliver high quality services across a range of planning, permitting and Environmental Impact Analysis (EIA) activities, including:</p><ul><li>Feasibility studies and land use planning appraisals</li><li style="">Environmental risk assessment</li><li style="">Site selection investigations</li><li style="">Regulatory impact assessments</li><li style="">Environmental statements</li><li style="">Assessments of environmental effects</li><li style="">Planning appeals support</li><li style="">Environmental management systems</li><li style="">Waste and energy minimisation / recovery studies</li><li style="">Risk assessments<br style="" /><br style="" /></li></ul>

Amec Foster Wheeler has a reputation for delivering high quality basic designs which give our clients a robust basis upon which to take their planned projects forward. This includes a full set of deliverables covering process and all technical disciplines as well as a project execution strategy, a consistent master project schedule and an open-book investment cost estimate – of appropriate accuracy – that can be used for project approval within our clients’ organisations.<br />&nbsp;<br />Whether our clients are planning a grassroots pharma or biopharma facility, a major upgrade or expansion, or a small ‘maintenance-type’ investment, we help them shape or re-shape their project to get the ‘green light’ to proceed with their investment, developing phased investment plans, optimising the investment, and using innovation and creativity to meet their objectives.<br />&nbsp;<br />What we provide is experienced design solutions from people who treat you not simply as clients but as business partners.

<p style="">We provide a complete engineering, procurement and construction management service for our clients.Our detailed design capabilities include specialist pharma and biopharma architectural, mechanical, electrical, automation, process and piping expertise, supported by state-of-the-art tools.<br style="" />&nbsp;<br />As well as working with our clients on the design of their facilities right from the concept design phase, through basic design and detailed design, we have global procurement capability and experience to develop and implement optimal contracting and purchasing strategies. Our strategies address the appropriate allocation of risk to manage project costs and time as well as contractors and suppliers. We use our knowledge base and experience to approach project delivery systematically. We align the contracting strategy with our clients’ needs and the attributes of a particular project.<br />&nbsp;<br />Our approach is to identify appropriate actions to address issues such as:</p><ul><li>Bulk and advance purchasing</li><li style="">Long-lead equipment</li><li style="">Workload of local suppliers and contractors</li><li style="">Diversity vendors and subcontractors</li><li style="">Site access constraints</li><li style="">All required insurances<br style="" /></li></ul><p style="">We have an in-depth understanding of the pharmaceutical / biotech Industry sector of the construction market, which has been significantly strengthened in the US by our recent acquisition of Yonkers Industries. We rely on solid management, a thorough understanding of the project scope and the ability to procure the best subcontractors and suppliers while managing to achieve successful outcomes within our clients’ cost objectives. We focus on construction early in the design phase and continue with the management of all construction activities to ensure the project is executed successfully.<br /><br />Our operations management support expertise ensures that in-depth and critical activities related to a large capital project with regard to validation, maintenance and operations are not overlooked and left until it’s too late. The validation and operations start-up phase of projects have the same, if not increased, level of requirements with regard to schedule activities and logic, resources, and deliverables as does the EPCM execution phase.&nbsp;</p>

We are recognised industry experts in validation, with teams of experienced validation and regulatory specialists providing the full spectrum of commissioning, qualification, and validation services. In fact, we co-authored the ISPE Commissioning and Qualification Guideline. We can offer our expertise as a standalone service, or as an integral part of our full EPCMV project delivery.<br />&nbsp;<br />From conceptual design through handover, our validation team works closely with engineering, manufacturing, procurement and construction to ensure that quality is designed into the project, that user requirements are achieved in the design, that regulatory concerns are addressed, and that commissioning and qualification needs are clearly communicated to the entire project team.<br />&nbsp;<br />At Amec Foster Wheeler we follow the “life-cycle” approach to commissioning, qualification, and validation. This defines the requirements for design, procurement, pre-delivery inspection, factory acceptance testing, installation, commissioning, and qualification (or verification) during the earliest project phases.<br /><br style="" /><p style="">We offer the following commissioning, qualification, and validation services:</p><table class="aloha-ephemera-attr" data-aloha-ephemera-attr="id" id="ab85b830-ea64-6de1-0d55-ff173e8d19f6"><tbody><tr><td style=""><ul><li>Development of user requirement specifications</li><li style="">cGMP audits and training</li><li style="">Vendor audits</li><li style="">Compliance programs</li><li style="">Design reviews</li><li style="">Design qualification</li><li style="">Validation master plans</li></ul></td><td style=""><ul><li>Commissioning master plans</li><li>Integrated scheduling</li><li>Program development</li><li style="">FAT/SAT assistance</li><li style="">Turnover packages</li><li style="">Commissioning</li><li style="">Equipment qualification (DQ, IQ, OQ, PQ)</li></ul></td><td style=""><ul><li>Computer system validation</li><li style="">Laboratory validation</li><li style="">System life-cycle documentation</li><li style="">GAP analysis</li><li style="">Support to development of SOPs</li><li style="">Summary reports</li><li style="">Recertification<br style="" /></li></ul></td></tr></tbody></table><p class="aloha-editing-p" style=""><br style="" /></p>

We provide comprehensive and cost-efficient solutions to meet our clients’ on-going maintenance management needs. Our engineers and technicians provide expertise and experience for our clients’ maintenance projects. We have extensive experience as employees of owner organisations and as service suppliers performing maintenance services for facilities, equipment and systems in the regulated pharmaceutical and biotech manufacturing facilities.<br />&nbsp;<br />We can support the development, implementation and operation of Computerised Maintenance Management Systems, work with our clients’ to maximise inventory dollars by stockroom optimisation and inventory management, and our experienced maintenance supervisors and engineers provide maintenance training, planning and troubleshooting services.

With in-depth environmental expertise, we can provide the full range of services, including remediation assessment, design of remediation measures, installation of remediation systems or plants and management of such remediation activities, up to the completion of the works due certified by the relevant Public Authorities and final release of the site.

At every part of the product life cycle, from R&amp;D through manufacturing, distribution and marketing of products, pharmaceutical companies must adhere to regulations from local, national and international authorities. We keep regulatory compliance firmly in our minds from the earliest phases of projects, from developing the conceptual design, applying the right codes and standards, managing the information required to demonstrate regulatory compliance, material selection and quality control, amongst many other factors.

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