Issues Guidelines and Suggestions

Acting as a consultant can result in new methods, techniques or tools producing more efficient or safer processing of the toll. In some cases, the toller may be the expert in the process or equipment thus consulting to their client company to help them gain expertise for contracting future tolls. 

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One of the primary issues repeatedly arising from the guideline and from the very nature of the complexities of process development, scale up, and eventual large-scale manufacture of biologies is what material is appropriate to use during the various stages of nonclinical development. As stated above, the material should be representative of the anticipated clinical material. This needs to be supported by data, namely identity, purity, stability, and potency. See Table 38.2 for suggested analytical tests for test article used in preclinical studies. 

The IHT guidelines describe how Road Safety Audits may be carried out on local streets in relation to advice given in Manual for Streets. In this case, it is recommended that Road Safety Audits should be carried out as part of a comprehensive quality audit. The use of risk assessments is also suggested for schemes in local streets as a way of prioritising the safety issues identihed, and a methodology for such assessments is included. 

The reader may wonder why process validation is included. This is simply a matter of consideration of the content of guidelines issued in the past that relate to development pharmaceutics. The first such pan-European guideline, adopted by the Committee for Proprietary Medicinal Products (CPMP) in 1988, included advice on both development pharmaceutics and process development. Later versions of the guidelines on development pharmaceutics and on process development have addressed these topics separately, but the historical and practical perspectives suggests that both need to be discussed here. 

Except for issues such as risk assessment and factors that would indicate the need to determine the potential effect of test article on immune function, the various guidelines are fairly consistent in what tests are recommended. ICH S8 contains a table suggesting the parameters that should be assessed in nonclinical toxicology studies these parameters do not differ significantly from other guidelines (see Table 2.1). The... 

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