Product Design Report

A useful outcome of the initial product design phase is a Product Design Report. This should document the careful evaluation of the following key elements ... 

The level of information on the dosage form and pack should provide sufficient clarity of detail to enable the Pharmaceutical Development group to plan their development. These pharmaceutical attributes may be documented separately in a pharmaceutical product profile . A typical example of a pharmaceutical product profile is shown in Table 5.2 for an intravenous injection product, illustrating the level of detail expected in a Product Design Report. 

These dimensions, performance limits and function/user test limits should be specified in the Product Design Report. 

There may be a variety of issues which should be documented in the Product Design Report to highlight the perceived risks involved in developing the product. Some of these risks will be related to pharmaceutical development and others to clinical, safety/toxicology or other areas. 

The importance of identifying these issues in a Product Design Report is to make the company aware of the risks it is taking and to make effective plans to overcome problems and manage the risks. 

The current patent status and potential for future patents to be obtained should be highlighted in the Product Design Report to assess the overall strength of patent protection to cover future development, and, as long as possible, market exclusivity. 

The Product Design Report can be a very useful document to focus the company on developing the right product at the right time to the market. Of course, to be of value it is essential that the correct input has been obtained from internal and external customers. For this to happen, a pharmaceutical company s senior management has to support this approach and ensure that time and resources are allowed for the design phase activities. The most successful pharmaceutical companies are effectively using this approach. 

It is important that the Product Design Report is reviewed by the project team at milestones in the project life and updated if necessary. It is imperative that some information will change with time, for example, competitor activity. The introduction of a new competitor product to the market with unexpected product attributes may result in a re-evaluation of the desired product profile for the new product being developed. This, in turn, can result in subsequent modifications to the preformulation and formulation development programme. It is hoped that this will not be a complete change in direction, but if it is, the product design review will have alerted the company sooner rather than later to address this, and not to develop a product that is not wanted or needed. 

The major objective of the product optimisation stage is to ensure that the product selected for further development (the intended commercial product) is fully optimised and complies with the design specification and critical quality parameters described in the Product Design Report (refer to Chapter 5). The key outputs from this stage of development will be... 

A logical approach to packaging optimisation is, first of all, to define the packaging function, followed by selection of the materials, then testing the performance of the packaging to ensure that it will meet all the product design and functional requirements that were identified in the Product Design Report. 

The excipient manufacturer should establish and maintain procedures to control and verify the design of the excipient to ensure that the specified requirements are met All information concerning the design process should be documented as part of a product design report or to be easily cross-referenced (e.g., computer records, laboratory notebooks, etc.). 

This listing is presented in outline form to identify, at a glance, the sections that are normal included in the sequence shown. The first four items are common to both process design ai product design reports. 

No one outline can apply to all product design reports. However, the following list may provide a starting point. 

The key determinants of future cost competitiveness of a-Si H PV technology are a-Si H deposition rates, module production yields, stabilized module efficiencies, production volume, and module design. Reported a-Si H deposition rates vary by more than a factor of 10, but most researchers report that the high quaUty films necessary for high stabilized efficiencies require low deposition rates often due to high hydrogen dhution of the Si (and Ge) source gases (see Semiconductors, amorphous). 

In principle, problems related to chemical product design can be formulated and solved in many different ways. The objective here is to highlight some of those that have also been applied in the various product design case studies reported in chapters 2-15 of this book. These solution approaches may be classified under the following types ... 

Feb Competition and Business Strategy Product Design (1) Indoor air survey (2) Prototype Chemical Design and Processing (1) Adsorbents (2) Catalysts. Process Safety Analysis Process Control and Instrumentation Environmental Impact Assessemsnt Report Writing... 

The second challenge is to relate the desired product attributes to the material properties of the ingredients and the structure of the product. For example, the development process would have been much more efficient if a model was available to describe the behavior of cleansing bars and structured food products. Without the benefits of predictive models, as is the present status for many consumer products, extensive trial-and-error by experiments are required. Even if a comprehensive model based on first principles is not available, a combination of physical insights and heuristics can still help improve the development process. Chapters 1-2 report some new developments in this area. See also [11] for a more detailed discussion on the issues and needs related to the roles and uses of property models in product design. 

With specially designed reactants, the determination of the product structure can be very informative. Mercury(II)-catalyzed aquations of Co(III) complexes are believed to proceed via a 5-coordinated intermediate (Sec. 4.3.2). The shape of this intermediate is of interest. The Hg +-catalyzed aquation of Co(NH3)4 (NDj)X + in which the ND, and X groups are trans to one another gives substantially rrans-Co(NH3)4(ND3)(H20). This is excellent evidence for a square pyramidal intermediate in the reaction. A trigonal-bipyramidal intermediate would be expected to lead to substantial scrambling of the NDj and NHj groups (Fig. 2.1). The definite but very small amount (2.8 0.4%) of cis product recently reported using NHj instead of NDj attests to the sensitivity of current nmr machines. 

Brooks GO, Cousins AR, CreUin RA (1974) Puff by puff impact - extractable nicotine studies on Hallmark cigarettes from Austraha report no. Rd. 1108-R. 21 May 1974. Brown Williamson. Bates 650318361-650318421. http //tobaccodocuments.org/bw/70032.html Brown Williamson (1977) Long-term product development strategy. 28 Nov 1977. Bates 501011512-501011515. http //tobaccodocuments.org/bw/90839.html Brown Wilhamson (1983) Directed flows of smoke. 17 Feb 1983. Bates 509001468-509001475. http //tobaccodocuments.org/product design/1334.html Browne CL (1990) The design of cigarettes, 3rd edn. C Filter Products Division, Hoechst Celanese Corporation, Charlotte, NC... 

Wood DJ (1976) Project WHEAT-Part 2. UK male smokers their reactions to cigarettes of different nicotine delivery as influenced by inner need. Report no, Rd,1322, 30 Jan 1976, British American Tobacco. Bates 650016374-650016466, http //tobaccodocuments.org/product design/ 17739.html... 

SEEBA workshop on Supply Chain Management Meeting Electronics Customer Environental Requirements, 30 April 2003, Centre for Sustainable Design, Farnham, UK Envirowise (2001) ENDS Report 321, Envirowise revamp brings advice on cleaner product design, October 2001. Envirowise is funded by the UK Department of Trade and Industry. See www.envirowise.org Apple (2005) Apple states its environmental policy with respect to materials at http //www.apple.com/ environment/design/materials/selection. html... 

There should be an oral presentation towards the end of the semester to the management (which is your classmates, the professor, and the invitees) on your business plan for a proposed new product on the innovative product idea, on market and technology analysis, on the financial and environmental analysis, and on your recommended action. Be prepared to answer searching questions from your management, and to hear constructive comments intended to improve your research, your analysis, your recommendation, and your presentation skills. If time permits, it would be useful to take all the comments and constructive suggestions into consideration, and make a second oral presentation. The product design project concludes with the submission of a written report, which would be in parallel with the traditional process design project. 

Shortly after the publication of the Amundson Report on the future of chemical engineering in 1989, Edward Cussler and 1 discussed the need for a book on products. Subsequently, he became the pioneer and coauthored the first modern book in product design. Neither of us has ever designed a product that became a winner in the marketplace. It is customary in our profession that those who write design books have never designed a chemical plant or an oil refinery, but those who have done so do not write. 1 am indebted to many friends who have participated in the design of successful... 

G.E.P. Box and S.P. Jones, Robust product designs, part II second-order models. Report No. 63 (1990), Center for Quality and Productivity Improvement, University of Wisconsin-Madison. 

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