NNE supports your business planning efforts by helping you to meet strategic goals, minimising risk, identifying opportunities for innovation and delivering solutions that provide the foundation for the success of a project. We do this through a range of front-end services and pharma consultancy within:
- Operational analysis
- Risk assessments
- Technology assessments
- 3D modelling
- GMP assessments
As pharma engineers, we base our recommendations on a deep understanding of your operational and implementation context combined with clear understanding of regulatory, technology and organisational implementation constraints and opportunities.
The front-loaded approach
The key to a successful pharma engineering project begins in the earliest and initial phases. These first steps in the overall lifecycle of a project are the most critical to the project’s success. This includes defining the business case, project goals and drivers, potential risks, compliance requirements, right quality level, technology strategy, capacity, cost, delivery methodology and execution capability.
Our front-loaded approach to projects encompasses a methodology where basic knowledge and information is clarified, analysed, challenged and captured before initial concept development and concept design is initiated. Our goal is to help you establish the proper foundation, before putting pen to paper – and to form a basis for decision and basis for design.
The purpose of the front-loaded approach is to provide a consistent and sequential structure to support planning and execution of projects in order to meet customer expectations and patient needs.
A risk-based and enterprise-wide approach to design
Regulatory authorities prompt the application of a science- and risk-based approach to pharmaceutical manufacturing. Thus, this approach also forms the foundation for how we do front-end design.
We know that risk can sink a project. At NNE, we have a clear, structured and consistent way of addressing risks – and we do it from the very beginning of the front-end and conceptual design execution. In fact, one of the outcomes of our conceptual design effort is identification and mitigation of risks. Our approach is driven by regulatory and customer requirements in order to help ensure the safety of your patients. In addition, the approach creates a solid basis for decision and design.
Risk-based design involves understanding the complete manufacturing enterprise, from material requirements through segregation strategy and the manufacturing platform(s) to finished product handling. NNE’s conceptual design methodology is thus based on a holistic approach that ties together:
- Product requirements
- Manufacturing process
The goal of our conceptual design work is to provide a clear approach and understanding of how the building elements must be defined and operated in order to ensure patient safety in the manufacture of the product. Thus, in our execution of conceptual designs, we put a strong focus on making sure that the design supports:
- Process-driven understanding around operational analysis, i.e. efficiency, throughput, utilisation, product risk and cost of goods
- Regulatory philosophy, including compliance risk mitigation, validation baseline philosophy, lifecycle product and process comparability, and market and guiding regulations
- Business drivers, e.g. flexibility, responsiveness to change, expansion, innovation
- Management needs, e.g. budgetary costs, implementation schedule, project risk identification and mitigation
- Integrated handover to detailed design activities
An inter-disciplinary effort
The process of establishing goals, collecting and analysing the relative data, determining needs vs. wants, and developing and testing concepts requires an integrated body of knowledge across a wealth of disciplines.
Leveraging our in-depth understanding of pharma operations, NNE helps clarify and prioritise needs and requirements. We identify to-be capabilities (technical, regulatory and organisational), create baseline (as-is and gap analyses), define and prioritise design principles and criteria, and create and evaluate design options. We also deliver business-oriented executive and operational plans and recommendations.
In the end, this provides you with a robust basis for decision and basis for design of potential facility investment projects. We strive to create the foundation for robust project execution, a design fit for the business intent, and in line with your implementation capabilities. Our goal is to reach innovative and efficient solutions to the most challenging manufacturing facility problems, focused on operability, compliance, utilisation and cost effectiveness.