Industry guidance overview

In Table 4, an overview is presented of the different experimental parameters of the CE analyses that are included in the analytical instructions part of the specific monographs mentioned above. Notice that the first 13 parameters (from capillary dimensions up to system suitability tests ) are those described in the FDA draft guidance for industry described in paragraph II From this overview it can be concluded that most experimental parameters required by the draft guidance are included in the specific monographs, currently published in the Ph.Eur. and USP. In the monograph for erythropoietin concentrated solution the injection parameters are not included. Only the injection mode (pressure or vacuum) is defined. Instead,... 

As discussed in the Appendix Overview, each issue is composed of four parts (1) a ISSUE statement section, which describes the safety concern, (2) a ACCEPTANCE CRITERIA section which discusses the applicable NRC guidance and regulations and industry codes, standards and/or other relevant requirements, (3) a RESOLUTION section which describes the technical bases for the resolution of the issue considering the System 80+ Standard Design, as described within CESSAR-DC or other relevant documentation (e.g., special technical reports) and finally, (4) a REFERENCES section which lists the references used in the formulation of the Issue Statement, Acceptance Criteria, and Resolution sections of the issue. 

This book, a special edition of the chapters Adhesives and Adhesive Tapes of Ulhnann s Encyclopedia of Industrial Chemistry, is intended as a guidance for everybody interested in getting an overview on the various adhesives, their different properties, and the wide field of applications. 

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