Product development, stages

The items to be tested for sterility should be tested for antimicrobial activity during the product development stages, if this is possible. If they are found to have such activity, preparatory or test procedures will need to be modified to neutralize this activity. If all items are found to be free of such activity when first tested or after modification of procedures, application of the test for antimicrobial activity to every sample is not necessary. 

In addition, simple binary studies with key excipients should be done to establish physical and chemical compatibility between the API and the selected excipient. These studies need not be elaborate, but will provide useful information to the formulator during the critical drug product development stage. 

Why are so many compounds "killed" in the product development stage Because the bottom line question in drug development asks, "Is this drug safe and effective in the human body " many of these compounds simply do not prove to be safe and effective in the human body. 

The number and type of viruses selected for spiking studies depends on the process materials (e.g., host cell) and product development stage [5]. Before phase... 

Supply uncertainty Free exchanges of information - starting with the product development stage and continuing with the mature and end-of-life phases of the product life cycle - have been found to be highly effective in reducing the risks of supplier failure. 

The performance of a method is expressed in terms of its specificity, sensitivity, accuracy, precision, detection and quantification limits, linearity, range, robustness, and ruggedness. In addition to the parameters listed above, other factors to be considered are simplicity and cost. The latter may be of less importance for methods used at the product development stage or for regulatory analysis but may be of considerable importance for routine quality control methods. 

In most cases, the different disciplines involved in the product development use tools that are not connected to each other. This situation is due to the fact that the different tools are proprietary and sometimes there is no standard specification that can be implemented as software interfaces or adapters to support the transmission of information from one System to another. The consequence of this fact often is the isolation of product development stages (see Fig. 27.3), which normally should be connected for tracking purposes and, therefore, managing complexity. Thus, the list of requirements commonly is not linked to functions, although functions are derived from requirements. 

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