DETERMINATION OF RELATED SUBSTANCES & IMPURITIES IN DRUGS BY ICH GUIDE LINES
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DETERMINATION OF RELATED SUBSTANCES & IMPURITIES IN DRUGS BY ICH GUIDE LINES







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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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Slide 1

DETERMINATION OF RELATED SUBSTANCES & IMPURITIES IN DRUGS BY ICH GUIDE LINES

BY

M.PAUL RICHARDS

Slide 2

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.

Slide 3

ANALYTICAL PROCEDURES

  • Suitable for detection & quantification of degradation products. (HPLC & TLC).

  • For determination of related substances & degradation products.

  • Sample stored under stress conditions (light , heat, humidity, acid/base hydrolysis & oxidation)

Slide 4

  • 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.

Slide 5

  • 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.

Slide 6

RESIDUAL SOLVENTS

  • 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.

Slide 7

For Isolating and Identifying process related Impurities using

  • MS

  • NMR

  • HPLC

  • FTICR-MS

  • LC-MS.

Slide 8

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.

Slide 9

OBJECTIVE

  • 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.

Slide 10

CO SPONSORS OF ICH.

  • EC-EU.

  • EFPIA.

  • MHW

  • JPMA

  • FDA

  • PRMA

Slide 11

FUNCTIONS.

  • HAS EQUAL PARTICIPATION IN THE PROCESS & EACH HAS TO SEAT ON THE STEARING COMMITTEE , WHICH OVERSEAS HARMONISATION ACTIVITIES.

Slide 12

WHO GOVERN ICH

  • 1.Six founder members of ICH.

  • 2.OBSERVERS:

    A.WHO B.EFTA

    C.HPB

    3.SECRETERIATES (PROVIDED BY JFPMA)

Slide 13

AREAS OF ICH GIDELINES

  • STABILITY.

  • ANALYTICAL VALIDATION.

  • IMPURITIES.

  • PHARMACOPOEIAS.

  • BIOTECHNOLOGICAL QUALITY.

  • GMP.

  • TOXICITY.

  • KINETICS.

  • REPRODUCTIVE KINETICS.

  • CARCINOGENCITY.

Slide 14

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 .

On the basis of “CONCEPT PAPER”

Slide 15

Individual Harmonisation topics

  • Safety.

  • Quality

  • Efficacy

  • Multidisciplinary

Slide 16

Status of ICH GUIDE LINES:

EFFICIENCY TOPICS

Slide 19

SAFETY TOPICS

Slide 21

QUALITY TOPICS

Slide 23

Selection of Topics

  • Step 1

  • Step 2

  • Step 3

  • Step 4

  • Step 5

Slide 24

BY


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