PRODUCT LIFE CYCLE MANAGEMENT IN PHARMACEUTICALS: A REVIEW
S.P.Sethy*, Tahseen Sameena, Prathima Patil, K.Shailaja
Department Of Pharmaceutical Chemistry.
Sushrut Institute of Pharmacy
Taddanpally (V), Pulkal (M), Medak-502293
The complexity of today’s pharmaceutical market requires more efficient drug development and production. Product Lifecycle Management (PLM) has the opportunity to make pharmaceutical production more effective and with lower risk – even in this vastly complex environment. The product lifecycle management creates and manages a company's product-related intellectual capital starting from an idea to its final retreat. In pharmaceutical industry, it benefits through enhancing the lifespan of patent and pricing strategies. Improved patient compliance, revenue growth, expanded clinical benefits; cost advantages life extension exclusivity and quicker market launch are amongst the main applications of product lifecycle management. Leaders are actively implementing PLM and are reaping the benefits of fewer problems, lower costs, higher yields, employees armed to make good decisions, and audits that make everyone more confident as they access the information they need. The present manuscript focuses on product lifecycle management, problems and the key solutions for a successful product lifecycle management in pharmaceuticals.
REFERENCE ID: PHARMATUTOR-ART-2051
Product lifecycle management(PLM) is the process of managing the entire lifecycle of a product from its conception, through design and manufacture, to service and disposal. PLM forms the product information backbone for a company and its extended enterprise. It is composed of multiple elements including: foundation technologies and standards (e.g., XML, visualization, collaboration, enterprise application integration, etc.), information authoring and analysis tools (e.g., mechanical design, electronics design, software engineering, technical publishing, finite element analysis, etc.), core functions (e.g., data vaults, document and content management, workflow, product structuring, program management, etc.), functional applications (e.g., configuration management, engineering change control, etc.), and business solutions (e.g., new product introduction, supply chain collaboration, etc.) that incorporate best practices and methods.
In recent years the pharmaceutical industry has faced declining R&D productivity,a rapidly changing healthcare landscape and fierce competition from generics resulting in lower growth and profit margins. Historically, drug development focused on clinical trials management and outcomes. Now however, the industry is looking at more holistic approaches to improve processes of bring new products to market that can accelerate product development while lowering operational costs. This is challenging because of the complex value chain and business processes required in this highly regulated environment. Additionally, it has proven difficult for the industry to effectively adapt as many pharmaceutical companies are simply not optimized for cross functional collaboration which is so desperately needed to support these changing market conditions. One meaningful and holistic approach to today’s current challenges within the pharmaceutical industry is to focus on Product Lifecycle Management (PLM), which is a business transformation approach to manage products and related information across the enterprise. In recent years PLM has provided many pharmaceutical organizations with the ability to increase their ability to get products to market quicker, ensure greater regulatory compliance and efficiencies while reducing development costs. This article identifies some key business metrics that benchmark a company’s performance and key strategic business processes required to improve R&D performance through a PLM business transformation approach.
PHASES OF PRODUCT LIFECYCLE AND RELATED TECHNOLOGIES:
PHASE 1: CONCEIVE [IMAGINE, SPECIFY, PLAN, INNOVATE]
The first stage is the definition of the product requirements based on customer, company, market and regulatory bodies’ viewpoints. From this specification, the product's major technical parameters can be defined. In parallel, the initial concept design work is performed defining the aesthetics of the product together with its main functional aspects. Many different media are used for these processes, from pencil and paper to clay models to 3D CAID (computer-aided industrial design software). In some concepts, the investment of resources into research or analysis-of-options may be included in the conception phase – e.g. bringing the technology to a level of maturity sufficient to move to the next phase. However, life-cycle engineering is iterative. It is always possible that something doesn't work well in any phase enough to back up into a prior phase – perhaps all the way back to conception or research. There are many examples to draw from.
PHASE 2: DESIGN [DESCRIBE, DEFINE, DEVELOP, TEST, ANALYZE AND VALIDATE]
This is where the detailed design and development of the products form starts, progressing to prototype testing, through pilot release to full product launch. It can also involve redesign and ramp for improvement to existing products as well as planned obsolescence. The main tool used for design and development is CAD. This can be simple 2D drawing / drafting or 3D parametric feature based solid/surface modeling. Such software includes technology such as Hybrid Modeling, Reverse Engineering, KBE (knowledge-based engineering), NDT (Nondestructive testing), and Assembly construction. This step covers many engineering disciplines including: mechanical, electrical, electronic, software (embedded), and domain-specific, such as architectural, aerospace, automotive ... Along with the actual creation of geometry there is the analysis of the components and product assemblies. Simulation, validation and optimization tasks are carried out using CAE (computer-aided engineering) software either integrated in the CAD package or stand-alone. These are used to perform tasks such as:- Stress analysis, FEA (finite element analysis); kinematics; computational fluid dynamics(CFD); and mechanical event simulation (MES). CAQ (computer-aided quality) is used for tasks such as Dimensional tolerance (engineering) analysis. Another task performed at this stage is the sourcing of bought out components, possibly with the aid of procurement systems.
PHASE 3: REALIZE [MANUFACTURE, MAKE, BUILD, PROCURE, PRODUCE, SELL AND DELIVER]
Once the design of the product’s components is complete the method of manufacturing is defined. This includes CAD tasks such as tool design; creation of CNC Machining instructions for the product’s parts as well as tools to manufacture those parts, using integrated or separate CAM computer-aided manufacturing software. This will also involve analysis tools for process simulation for operations such as casting, molding, and die press forming. Once the manufacturing method has been identified CPM comes into play. This involves CAPE (computer-aided production engineering) or CAP/CAPP – (production planning) tools for carrying out factory, plant and facility layout and production simulation. For example: press-line simulation; and industrial ergonomics; as well as tool selection management. Once components are manufactured their geometrical form and size can be checked against the original CAD data with the use of computer-aided inspection equipment and software. Parallel to the engineering tasks, sales product configuration and marketing documentation work take place. This could include transferring engineering data (geometry and part list data) to a web based sales configuration and other desktop publishing systems.
PHASE 4: SERVICE [USE, OPERATE, MAINTAIN, SUPPORT, SUSTAIN, PHASE-OUT, RETIRE, RECYCLE AND DISPOSAL]
The final phase of the lifecycle involves managing of in service information. Providing customers and service engineers with support information for repair and maintenance, as well as waste management/recycling information. This involves using tools such as Maintenance, Repair and Operations Management (MRO) software. There is an end-of-life to every product. Whether it be disposal or destruction of material objects or information, this needs to be considered since it may not be free from ramifications.
PRODUCT AND PROCESS LIFECYCLE MANAGEMENT (PPLM):
Product and process lifecycle management (PPLM) is an alternate genre of PLM in which the process by which the product is made is just as important as the product itself. Typically, this is the life sciences and advanced specialty chemicals markets. The process behind the manufacture of a given compound is a key element of the regulatory filing for a new drug application. As such, PPLM seeks to manage information around the development of the process in a similar fashion that baseline PLM talks about managing information around development of the product. One variant of PPLM implementations are Process Development Execution Systems(PDES). They typically implement the whole development cycle of high-tech manufacturing technology developments, from initial conception, through development and into manufacture. PDES integrate people with different backgrounds from potentially different legal entities, data, information and knowledge and business processes.
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