Determination of related substances impurities in drugs by ich guide lines
Download
1 / 25

DETERMINATION OF RELATED SUBSTANCES IMPURITIES IN DRUGS BY ICH ... - PowerPoint PPT Presentation


  • 897 Views
  • Uploaded on

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.

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'DETERMINATION OF RELATED SUBSTANCES IMPURITIES IN DRUGS BY ICH ...' - arleen


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript

Introduction l.jpg
INTRODUCTION ICH GUIDE LINES

  • 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 l.jpg
ANALYTICAL PROCEDURES ICH GUIDE LINES

  • 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)


Slide4 l.jpg

  • 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.


Slide5 l.jpg


Residual solvents l.jpg
RESIDUAL SOLVENTS used to estimate ,identify & unidentify deg.products.

  • 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.



Ich guidelines international conference on harmonization l.jpg
ICH GUIDELINES (INTERNATIONAL CONFERENCE ON HARMONIZATION) using

  • 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.


Objective l.jpg
OBJECTIVE using

  • 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 l.jpg
CO SPONSORS OF ICH. using

  • EC-EU.

  • EFPIA.

  • MHW

  • JPMA

  • FDA

  • PRMA


Functions l.jpg
FUNCTIONS. using

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


Who govern ich l.jpg
WHO GOVERN ICH using

  • 1.Six founder members of ICH.

  • 2.OBSERVERS:

    A.WHO B.EFTA

    C.HPB

    3.SECRETERIATES (PROVIDED BY JFPMA)


Areas of ich gidelines l.jpg
AREAS OF ICH GIDELINES using

  • STABILITY.

  • ANALYTICAL VALIDATION.

  • IMPURITIES.

  • PHARMACOPOEIAS.

  • BIOTECHNOLOGICAL QUALITY.

  • GMP.

  • TOXICITY.

  • KINETICS.

  • REPRODUCTIVE KINETICS.

  • CARCINOGENCITY.


Slide14 l.jpg

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”


Individual harmonisation topics l.jpg
Individual Harmonisation topics groups for which a RAPPORTEUR.

  • Safety.

  • Quality

  • Efficacy

  • Multidisciplinary


Status of ich guide lines l.jpg
Status of ICH GUIDE LINES: groups for which a RAPPORTEUR.

EFFICIENCY TOPICS


Safety topics l.jpg
SAFETY TOPICS groups for which a RAPPORTEUR.


Quality topics l.jpg
QUALITY TOPICS groups for which a RAPPORTEUR.


Selection of topics l.jpg
Selection of Topics groups for which a RAPPORTEUR.

  • Step 1

  • Step 2

  • Step 3

  • Step 4

  • Step 5


Slide24 l.jpg
BY groups for which a RAPPORTEUR.


ad