台大資工app網站相關資料
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GLP Booklet
The various acts enforced by FDA require an adequate showing of product safety prior to introduction into the marketplace. In order to ensure adequate …
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BLA Booklet
The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate comm …
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PMA 510k Booklet
Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. PMA regulates most Class III medical device. A PM …
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ICH Q10 Guidebook
The ICH Q10 - Pharmaceutical Quality System is a harmonized Guideline in USA, Europe and Japan and was approved in 2008. This Guideline applies to pha …
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GCP Booklet
Adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critic …
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ICH Q7 Guidebook
The ICH Q7 Guide "GMP for APIs" (formerly known as ICH Q7A) is a harmonized Guideline in USA, Europe and Japan and was approved in 2000. The guideline …
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QSR Booklet
Medical Device Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements an …
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