A hazard-evaluation program is established to obtain safety--related information for process development. This program identifies potential hazards and establishes protective safeguards by evaluating all components of the process at key stages of development. Hazard evaluation in developmental process must be sufficiently flexible to adapt to process changes. Several new critical issues regarding hazard evaluation are identified and general considerations discussed.Process development in pharmaceutical and chemical research is itself complicated. It begins with the transfer of technology from the discovery laboratory and ends with a manufactured product, or a less-successful conclusion. Development may take several years or just a few months, during which the process undergoes frequent and significant change. Process development can be an exciting as well as a frustrating endeavor; it is seldom routine, or without hazard. Safety in process development is always an important consideration and a challenging and rewarding undertaking.The goal of process development is to provide an efficient and safe process for manufacture. Thus, a considerable amount of very detailed safety information is obtained and designed into the final production process. At the initial stage of development (upon transfer from the discovery laboratory) there is little safety-related data available and the potential hazards are uncharacterized. Faced with a lack of safety information process development has two major responsibilities: safeguarding personnel and facilities during development and providing a safe process for production. To accomplish these objectives, an effective hazards evaluation program must be established within process development. Ideally, the hazards-evaluation program should be constructed to review each process at several key stages. This review should identify potential hazards associated with a process. These hazards should be evaluated by internal personnel with expertise in related disciplines, who establish the procedures to control these hazards. Once safeguards have been
Aus den Furanen (I) erhält man in einer Eintopfreaktion durch Umsetzung mit 2 Mol Chlor in wäßrigem Methanol bei ca. 0°C und anschließendes Erhitzen auf 90°C Maltol (Va) und das Ethylderivat (Vb).
Die beiden Furyl‐carbinole (I) werden in Gegenwart von Methanol chloriert und die Einschiebungsprodukte (II) erhalten, die über eine Chlorierung und De‐ Hydrochlorierung in (III) übergehen.
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