Hot Topic of The Season: Spectroscopy USP - Agilent

[Pages:34]Hot Topic of The Season: Spectroscopy USP

Paul Smith Global Strategic Compliance Program Manager Agilent Technologies, Inc. August 20, 2015 .

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E-Seminar Structure

Can't answer detailed questions about specific Analytical Methods, or Instruments or Monographs.......

Contents

A. Pharmacopeia Structure

Context and Reference Information

However, if you have a specific compliance question related to Pharmacopeia & you would like an answer - use the on-line system to ask, and we will provide reference information.

B. Changes to USP Spectroscopy Chapters

A key part of this e-Seminar is to provide educational insight into Pharmacopeia compliance.

C. Spectroscopy Comparison

Across USP, Ph. Eur. & JP

Questions ?

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Pharmacopeia Structure

References and USP Spectroscopy Changes

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Detailed Comparison

2012

Presentations:

? From 22 Pharmacopeia's

Links:

? Meeting Report ? Meeting Summary ? Index of Pharmacopeia's ? Review of World Pharmacopeia's

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Pharmacopeia's Are Not Harmonised !

Not Harmonised: ? Structure ? Contents ? Details (monograph / general)

2012

Lists

Pharmacopeia

Requirements

For 46

Countries

? Argentina ? Austria ? Belarus ? Belgium ? Brazil ? China ? Croatia ? Czech Republic ? Denmark ? Egypt ? Finland ? France ? Germany ? Greece ? Hungary ? Iceland ? India ? Indonesia ? Iran ? Ireland ? Italy ? Japan ? Kazakhstan ? Korea ? Lithuania ? Mexico ? Montenegro ? Norway ? Pakistan ? Philippines ? Poland ? Portugal ? Serbia ? Romania ? Russian Federation ? Slovakia ? Slovenia ? Spain ? Sweden ? Switzerland ? Thailand ? Turkey ? Ukraine ? United Kingdom ? USA ? Viet Nam ? Europe ? Africa ? WHO

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WHO - Review of Pharmacopoeias

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WHO - Review of Pharmacopoeias

Analysis of Content:

Countries in Europe:

? Follow the Ph. Eur ? May have National Pharmacopeia ? e.g. BP and Ph. Eur....

Greater speed of response / flexibility Care when Supplying with a country requirement !

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Compliant Analysis of Samples ? Is Influenced By:

Laboratory compliance requirements are influenced by:

Quality System

? ?WhWahtast asmampplelessyyou tteesstt ? ?WhWahtaat naanalylyssisis yyou ddoo ? ?WhWahtadt edcecisisioionnss tthhee rreessuultlstsaraeruesuesdefodrfor

Laws & Regulations Supply

[Products & Services]

How you perform the Test Monograph requirements ? of the Pharmacopeia

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