Pharmaceutical industry product cycle

It is widely understood within the industry that risk is defined as the combination of the probability of harm and the severity of that harm. Within the pharmaceutical industry whenever risk is considered the equipment or product being assessed must be viewed in the context of the protection of the patient. From our perspective, analytical instruments may impact on the validity of data that determines the safety and efficacy of drug products, or on the quality of the drug product. They may also impact on the identity or potency of the drug product and therefore it is important to ensure that risk management is performed throughout the complete life cycle of the instrument. 

In conclusion, the important role of the microbiologists in the pharmaceutical industry should be reinforced. The need to involve experieneed mierobiologists in each stage of the product life cycle to maintain high quality, safety, and efficacy is highlighted in this article. 

The second part deals with applications of solvent extraction in industry, and begins with a general chapter (Chapter 7) that involves both equipment, flowsheet development, economic factors, and environmental aspects. Chapter 8 is concerned with fundamental engineering concepts for multistage extraction. Chapter 9 describes contactor design. It is followed by the industrial extraction of organic and biochemical compounds for purification and pharmaceutical uses (Chapter 10), recovery of metals for industrial production (Chapter 11), applications in the nuclear fuel cycle (Chapter 12), and recycling or waste treatment (Chapter 14). Analytical applications are briefly summarized in Chapter 13. The last chapters, Chapters 15 and 16, describe some newer developments in which the principle of solvent extraction has or may come into use, and theoretical developments. 

ABC Pharmaceutical Industries information. The equipment preparation pages of the master batch record specify the validated sterilization processes to be employed in the preparation of the equipment for (product name) USP. Cycle sterilization parameters are defined along with attributes such as loading patterns and the mechanics of operating the sterilizing equipment. The following lists the sterilization cycles utilized for the equipment required in the processing of (provide product name) USP ... 

Figure 3.1 identifies the major stages in a solvents life cycle production, transport, use, and disposal. Although there are many opportunities to recycle and reuse solvents they will eventually need to be disposed of as waste. As an example, consider a process which uses tetrahydrofuran (THF). A 1 kg reduction in the amount ofTHF would reduce the CO2 emissions from THF production by about 16kg [3], This reduction in CO2 emissions does not account for the savings in transportation or disposal of excess THF in a process. Therefore, reductions in solvent use by the pharmaceutical industry not only reduce the waste it produces as part of its processes but also the waste that would be generated from the manufacture of additional solvent. 

The pharmaceutical industry now faces compelling demands to improve the productivity of analyses and shorten drug discovery and development time cycles. An impressive number of drug candidates generated by modern synthesis and combinatorial libraries requires screening of many samples. Some examples of the usefulness of the IPC strategy will be discussed below. 

The weak point of freeze-drying is its low productivity (expressed in number of cycles per year) and its cost. Pharmaceutical industry constraints, operation under vacuum, and the implementation of the sublimation phenomenon indeed require great investments, large energy consumption, and production delays far above those required with more classical dehydration techniques industrial... 

In the pharmaceutical industry, the term of patent life is a very important factor. Because patents are filed very early in the life cycle of a new pharmaceutical product and much premarketing testing is needed before the health authorities will permit public sale of a product, a large portion of patent life is lost. Often, the term effective patent life for pharmaceutical products is used. Studies by the Pharmaceutical Research and Manufacturers of America have shown that effective patent life for pharmaceutical products averaged 15 years in the early 1960s and declined to... 

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