Changes in manufacturing sites

In the case of a successful Level A correlation, an in vitro dissolution curve can serve as a surrogate for in vivo performance. Therefore, a change in manufacturing site, method of manufacture, raw material supplies, minor formulation modification, and even product strength using the same formulation can be justified without the need for additional human studies. 

Consist of a change in manufacturing sites to different campus11 To qualify same equipment, SOPs, environmental conditions and controls should be used in the manufacturing process at the new site, and no changes may be made to the manufacturing batch records except for administrative info, location, and language translation, where needed. 

Consist of change in manufacturing sites to different campus1... 

In spite of differences in the scale, and perhaps also in the design of the equipment used, a careful examination of the data will show which key factors in particular need to be controlled. It is easier to modify the method and scale of manufacturing where one is dealing with a properly and systematically studied process. Identification of critical factors will have shown which factors in scale-up are most likely to affect the finished product. Similar considerations apply to a change in manufacturing site. Designs used in scale-up are reviewed in chapter 7. 

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