Product Development Issues

The important factors in the use of PP have been discussed throughout the text. However, the purpose of this section is to compile them on the basis of their relevance at different stages of the life of the PP artefacts. Further information about these sensitive issues can be obtained from the relevant sections of this book. 

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Tools and techniques can enhance the success of a product, but alone they will not solve all product development issues (Jenkins et al., 1997a). Any implementation of tools and techniques within the product development process must take the following into account if the outcome is to be effective at all ... 

The Safer Detergents Stewardship Initiative (SDSI) addressed key environmental, economic, and product development issues in the surfactant world to drive change, especially in the cleaning products industry. Many companies were aware of the concerns for NPEs and with the growing number of alternatives that could offer equivalency in function and cost. Some had proactively switched to safer surfactants. 

TRACS International has provided training and consultancy In Exploration and Production related issues for many clients world-wide since 1992. This book has gradually developed from course materials, discussions with clients and material available in the public domain. 

ISO 9000. The ISO 9000 series of standards was first issued in 1987 and then updated in 1994. The ISO 9000 standard describes the selection criteria for the four standards, ISO 9001—9004. ISO 9001 is composed of 20 items covering manufactured products from design and development in R D to commercial production and after-sale service or technical support. ISO 9002 has 19 of the items in 9001 describing the requirements of a quahty system for the manufacture of an item, such as chemicals, to a specification only the requirement relating to product development is omitted. Chemical companies seldom certify to ISO 9003, which describes the quahty system for a laboratory involved in final inspection and test. Finally, ISO 9004 presents guidelines for total quahty management. 

A summary of each of the key tools and techniques considered to be important in the product development process is given in Appendix III. This covers such techniques as FMEA, QFD, DFA/DFM and DOE. Included for each is a description of the tool or technique, placement issues in product development, key issues with regard to implementation, and the benefits that can accrue from their use, and finally a case study. It would be advantageous next, however, to determine exactly what a tool or technique does. In general, the main engineering activities that should be facilitated by their use are (Huang, 1996) ... 

A proposed product development process that facilitates designing capable and reliable products has been outlined above. It must be stressed that the product development process itself will not produce quality products, and consideration of many issues are crucial to success, such as company strategy, management structure, commitment, sufficient resources, communication, and most importantly proficient engineering practices, such as the following. 

Whereas Freeman and Lewis reported the first comprehensive analysis of hydroxymethylation of phenol, they were not the last to study this system. A number of reports issued since their work have confirmed the general trends that they discovered while differing in some of the relative rates observed [80,84-99], Gardziella et al. have summarized a number of these reports ([18], pp. 29-35). In addition to providing new data under a variety of conditions, the other studies have improved on the accuracy of Freeman and Lewis, provided activation parameters, and added new methodologies for measuring product development [97-99],... 

Comprehensive physicochemical characterization of any raw material is a crucial and multi-phased requirement for the selection and validation of that matter as a constituent of a product or part of the product development process (Morris et al., 1998). Such demand is especially important in the pharmaceutical industry because of the presence of several compounds assembled in a formulation, such as active substances and excipients, which highlights the importance of compatibility among them. Besides, variations in raw materials due to different sources, periods of extraction and various environmental factors may lead to failures in production and/or in the dosage form performance (Morris et al., 1998). Additionally, economic issues are also related to the need for investigating the physicochemical characteristics of raw materials since those features may determine the most adequate and low-cost material for specific procedures and dosage forms. 

Innovation - advocates and opponents origin from microtechnology list of microfabrication techniques selectivity and efficiency as main driver for industrial implementation special properties and general advantages of micro reactors process-development issues BASF investigations on liquid/liquid and gas-phase reactions micro reactors as ideal measuring tools production in micro reactors as exception, the rule will be transfer to mm-sized channels [111],... 

One of the unique issues in the development of advanced-performance materials is that they are very product-specific, and their development requires expensive prototype iteration and performance testing. The product development is people- and design-intensive and usually results in a niche market for the material that is, the specific product slate for which the material has been designed and tested. Many of the applications are in high-tech industrial products like aerospace components, so the total volume of material used will be small. Thus, attractive commercialization schemes require that the material have intrinsic value that will justify a high margin, or there must be a product application for which the value can be captured in the end product. 

The availability of unpreserved and preserved dosage forms is considered. Mention is made of formulation changes necessitated by multidose products. The need for adequate antimicrobial preservative efficacy can be discussed if this was an issue during product development. 

The volume is divided into five sections. Part one looks at the experimental study of membrane permeability and oral absorption. In Part two, problems of measuring and prediction solubility, as one of the key determinants in the absorption process, will be discussed in detail. In the next part, progress in the science around transporter proteins and gut wall metabolism and their effect on the overall absorption process is presented. Part four looks at the in silico approaches and models to predict permeability, absorption and bioavailability. In the last part of the book, a number of drug development issues will be highlighted, which could have an important impact of the overall delivery strategies for oral pharmaceutical products. 

Chemistry under extreme or nonclassical conditions is currently a dynamically developing issue in applied research and industry. Alternatives to conventional synthetic or waste-treatment procedures might increase production efficiency or save the environment by reducing the use or generation of hazardous substances in chemical production. 

Problem definition A colleague from the cookies product development department of your company has come to your office to describe what appears to be a significant business issue. Complaints of an off-flavor in your chocolate chip cookies, sold throughout the country, are being reported. Samples of the product are being shipped from the plant by overnight air. Production has been stopped. A recall of all product is under consideration Identification of the off-flavor and its cause are now your top priority ... 

In the EU, the CPMP issued a draft Note for Guidance on Safety Pharmacology Studies in Medicinal Product Development in 1998, but it has not yet been finalized or put in force, and as of the middle of 2001, USFDA has remained mute on guidelines. 

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