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Active pharmaceutical terminology

The term validation is often misunderstood by IT professionals not familiar with pharmaceutical industry terminology. Validation has often erroneously been seen as limited to a testing activity at the end of a software/ hardware project. Validation in the pharmaceutical industry is closely aligned to the principle of quality assurance, which is a holistic approach that aims to build quality attributes into a system rather than verifying quality through testing. A system that is built according to... [Pg.86]

MedDRA the Medical Dictionary for Regulatory Activities terminology is the international medical terminology developed imder the auspices of the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use 2012. [Pg.91]

Sterility is the absence of viable micro-organisms [1]. Sterilisation is an active, validated process in order to kill micro-organisms. It is the most critical step in the preparation of sterile medicinal products, sterile medical instraments and sterile pharmaceutical utensils. These methods are used to obtain sterile medicines, active substances, medical devices or devices used in pharmaceutical production equipment. Sterilisation of healthcare products makes use of many specific terminology this may be found in ISO [2] as well in the EU-GMP Annex 1 [3]. [Pg.678]

This book chapter dwelt upon the pivotal role of catalysts in organic synthesis, specially focusing on its large-scale applications in the formation of C-C and C-0 bonds. The predominant application of catalysis in the fine chemical and pharmaceutical industrial sectors was an account of their focus on achieving increased efficiency in terms of activity and selectivity enroute to environment friendly products and processes. Though, pharmaceutical industry rarely reports the catalyst s activity in terms of TON and TOP, these terminology was employed to have a better understanding on the eatalyst performance under industrial environment. [Pg.363]


See other pages where Active pharmaceutical terminology is mentioned: [Pg.274]    [Pg.10]    [Pg.206]    [Pg.823]    [Pg.33]    [Pg.502]    [Pg.15]    [Pg.205]    [Pg.14]    [Pg.476]    [Pg.468]   
See also in sourсe #XX -- [ Pg.5 ]




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