Good manufacturing practice characterization

Adequate documentation forms an essential part of good manufacturing practice. For this reason, every aspect of pharmaceutical manufacture is characterized by the existence of extensive associated documentation. This is essential in order to ... 

There is a close relationship between the comparability of product made in different processes and in the applied current good manufacturing practices (cGMPs). The FDA has recognized that degree of GMP does not have to be as stringent for products in early phases of development [19,20], It should also be noted that the better a product is characterized, the easier it is to demonstrate that a new process produces a comparable product. 

Once the porous siUcon microparticles have been fabricated, they must be carefully characterized to insure that the desired particle specifications have been achieved and that there is minimal batch-to-batch variation. Good Manufacturing Practice (GMP) must be maintained to ensure repHcabUity of microparticle fabrication between lots and to exclude particle structural variabUity as a source of experimental observation in biological experiments. Given the complexity and size scales involved with the internal stracture of these microparticles, a battery of techniques must be employed to quantify the important metrics, such as porosity, pore size, density, interior volume, surface area, surface charge and surface modification. 

Commercial and non-commercial carbons were tested for their applicability as anode of lithium-ion battery. It was found that Superior Graphite Co s materials are characterized both by high reversible capacities and low irreversible capacities and thus can be regarded as good candidates for practical full cells. Cylindrical AA-size Li-ion cells manufactured using laboratory techniques on the basis of SL-20 anode had initial capacities over 500 mAh (volumetric energy density ca. 240 Wh/dm3). Boron-doped carbon... 

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