DETERMINATION OF RELATED SUBSTANCES & IMPURITIES IN DRUGS BY ICH GUIDE LINES. BY M.PAUL RICHARDS. INTRODUCTION. ANALYTICAL PROCEDURES. RESIDUAL SOLVENTS ICH GUIDELINES CO - SPONSORS OF ICH. WHO GOVERN ICH AREAS OF ICH GUIDE LINES. THE STATUS OF ICH GUIDE LINES. ANALYTICAL PROCEDURES.
DETERMINATION OF RELATED SUBSTANCES & IMPURITIES IN DRUGS BY ICH GUIDE LINES
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Other peaks should be labelled in the chromatogram & discussed in documentation.
Quantification limit is >/ the reporting threshold.
Deg.product should be compared with analytical response of Deg.product to that of appropriate REFERENCE STD.
REFERENCE STD : Control of deg .products should be
evaluated & to their Intended use.
Should be validated for specified & unspecified conditions & used to estimate ,identify & unidentify deg.products.
Diff.used during development proposed to commercial
product should be discussed.
Determine by using C.Technique such as GC.
Those describe in pharmacopoeias can be used for determination .
If only class 3 solvents are present ,non specific method
used on loss on drying.
For Isolating and Identifying process related Impurities using
ICH GUIDELINES (INTERNATIONAL CONFERENCE ON HARMONIZATION)
DEF: This is a process by which the organising authorities of the US, European commission Japan & experts from pharmaceutical industries & the trade association in the three region are brought together to discuss about the scientific and technical aspects of PRODUCT REGISTRATION.
To discuss scientific & technical aspects of medicinal product registration.
Discuss b/w regulatory authorities and the pharmaceutical industry on the real and perceived differences.
To identify an area where modification in technical requirements could lead to a more economical use .
To make recommendations on practical ways.
To achieve greater harmonisation in interpretation & application of technical guidelines & requirements for registration.
CO SPONSORS OF ICH.
HAS EQUAL PARTICIPATION IN THE PROCESS & EACH HAS TO SEAT ON THE STEARING COMMITTEE , WHICH OVERSEAS HARMONISATION ACTIVITIES.
WHO GOVERN ICH
1.Six founder members of ICH.
3.SECRETERIATES (PROVIDED BY JFPMA)
AREAS OF ICH GIDELINES
4 EWG is further divided into a member of working topic groups for which a RAPPORTEUR.
STEERING COMMITTEE IS ADVISED BY EXPERT WORKING GROUP ON TECHNICAL ISSUES .