Monitoring procedures, method transfer process

In practice, the sheer nature of the dynamic validation process results in a substantiation of the original validation throughout the useful life of the method. As previously mentioned, a well-developed and-written method includes system suitability that must be met each time the method is performed. Additionally, the pharmaceutical industry has standardized on the need of formal method transfer exercises whenever an analytical method is to be performed by a different laboratory or in another facility. Also, change control procedures may require the revalidation of part or all of the method in the event of changes to the method, the process, or the formula of a drug product. The QAU should therefore have a system to formally monitor the... 

The analytical procedures which have been developed especially to control and to monitor the efficacy of each bio-pro-cess step need also to be defined and to be transferred (see Part VII, Chapter 1). Protocols must be written that describe each in-process-control (IPC) step from the analysis of the WCB cell line, the (on-line) monitoring of the cultivation to the analysis of the purification need to be established. Due to the complexity of bioprocesses, the need for good biochemical analytical methods and capabilities cannot be overemphasized. 

Radiation chemistry can he used to study reactions of free radicals and of metal ions in unusual valency states, including electron-transfer reactions. In some instances, radiation chemistry facilitates experiments that can not he studied hy photochemistry, owing to differences in the fundamental physical processes in the two methods. Procedures have heen developed to accurately determine radiolysis radical yields, and a variety of physical techniques have heen used to monitor reactions. In particular, aqueous radiation chemistry has heen extensively developed, and many free radicals can he generated in a controlled manner in aqueous solution. There are extensive literature resources for rate constants and for experimental design for a variety of radicals. 

Thin fQm of molecularly imprinted polymer can be prepared on a SPR chip, and the specific binding activity can be monitored as a change in angle for tight reflected from the chip. However the preparation of molecularly imprinted polymer on the chip requires often a careful control of polymer composition. The most common method involves the free radical polymerization with the use of a photo-initiator, and this process can lead to changes of template structure in the case of proteins their denaturation occurs. Other preparation procedures of molecularly imprinted polymers for SPR are atom transfer radical polymerization and polymer grafting method these methods provide a better control of the film physical characteristics, but require a suitable catalyst for polymerization. 

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