Planning and Managing Product Development

Knowledge of the essential registration requirements is mandatory for the planning of a development project. If these are neglected, the development process will be like navigation in unknown waters without a compass or a map. The risk of a shipwreck is high, in any case the journey will take much longer and will cost more. 

Provided that a reasonable and useful product profile (see Table 2, above) has been established, the general aim of the project and the most relevant objectives have already been decided. As with most research projects, these will most likely address the efficacy, this time with more qualifications concerning the exact indication, the type of product, its formulation and application scheme. 

Another important general objective which has been defined in the product profile may be the expected price limit for the production of the active ingredient or the formulated product. Specific tasks and measurable success criteria for process development and manufacturing, e.g. in terms of yields and recovery after purification, can be deduced from this price limit. Other very specific objectives and the majority of project tasks relate to specific registration requirements. 

It may take several months to establish a workable development plan and most of this time will be required to collect the neccessary information. At the beginning the project plan will probably be a rather simple outline which then grows while the project progresses. A project master plan which covers the major sections, milestones and decision points can be established far ahead and - if prepared thoroughly- will remain essentially unchanged from then on. More specific and detailed planning and updating for the nearer future is done in the subordinated plans for the individual sections and must be performed continuously. 

Development plans must be much more detailed than research plans. The simple reason for this is that the commercial environment in which 

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The most difficult and controversial part in the planning and managing of a development process is to keep the right balance between the three cornerstones cost, risk, and time. Using more time reduces the risk but increases the cost and delays the product launch. Controller and marketing manager will raise their protest. Taking more risks increases... 

This book is an attempt to summarize information on the fundamentals of pharmaceutical product development for modern biomedicinal products and to combine these with specific recommendations for effective planning and management of applied research and development projects. A reasonable selection of information was necessary to avoid confusions by too many details. This inevitably leads to omissions and simplifications, particularly on patent and registration issues. The reader should bear in mind that these sections are primarily intended to... 

Report of a December 1979 visit by a US delegation of specialists to study the Soviet experience in planning and management of research and development, and the introduction of the results of R D in "Science-Production Associations" (N.P.O.s). 

Introduction and Commercial Application The reservoir and well behaviour under dynamic conditions are key parameters in determining what fraction of the hydrocarbons initially in place will be produced to surface over the lifetime of the field, at what rates they will be produced, and which unwanted fluids such as water are also produced. This behaviour will therefore dictate the revenue stream which the development will generate through sales of the hydrocarbons. The reservoir and well performance are linked to the surface development plan, and cannot be considered in isolation different subsurface development plans will demand different surface facilities. The prediction of reservoir and well behaviour are therefore crucial components of field development planning, as well as playing a major role in reservoir management during production. 

The operations group will develop general operating and maintenance objectives for the facilities which will address product quality, costs, safety and environmental issues. At a more detailed level, the mode of operations and maintenance tor a particular project will be specified in the field development plan. Both specifications will be discussed in this section, which will focus on the input of the production operations and maintenance departments to a field development plan. The management of the field during the producing period is discussed in Section 14.0. 

The way many companies identify resource requirements is to solicit resource budgets from each department covering a 1 to 5 year period. However, before the managers can prepare budgets they need to know what requirements they will have to meet. They will need access to the corporate plans, sales forecasts, new product development plans, marketing plans, production plans, etc. as well as the quality policies, objectives, and procedures. 

The standard requires systems to be in place to ensure management of appropriate activities during concept development, prototype, and production according to customer advanced product quality planning and control plan manual or project management manual. 

A logical first item is overall planning and development of the framework for the RM project. It includes consideration of end-use requirements of the material and provision for scientific and technical management and execution of the project by trained, dedicated, critical scientists and technologists. End-use requirement dictates an assessment of the nature of the problem to be addressed by the product, the market requirements, the analytical methods to be served, the measurands, forms and concentrations to be certified, the level of certification required, and the quantities of starting and final product needed, leading to overall definition of the undertaking. 

Develop recommendations to improve the management and staff support of safety with the same enthusiasm, attention, quality, plans, and organization as used in production programs. 

In addition to their use as stand-alone systems, LPs are often included within larger systems intended for decision support. In this role, the LP solver is usually hidden from the user, who sees only a set of critical problem input parameters and a set of suitably formatted solution reports. Many such systems are available for supply chain management—for example, planning raw material acquisitions and deliveries, production and inventories, and product distribution. In fact, the process industries—oil, chemicals, pharmaceuticals—have been among the earliest users. Almost every refinery in the developed world plans production using linear programming. 

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