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1. DETERMINATION OF RELATED SUBSTANCES & IMPURITIES IN DRUGS BY ICH GUIDE LINES BY
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)
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.
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.
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.
7. For Isolating and Identifying process related Impurities using MS
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.
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.
10. CO SPONSORS OF ICH. EC-EU.
11. FUNCTIONS. HAS EQUAL PARTICIPATION IN THE PROCESS & EACH HAS TO SEAT ON THE STEARING COMMITTEE , WHICH OVERSEAS HARMONISATION ACTIVITIES.
12. WHO GOVERN ICH 1.Six founder members of ICH.
3.SECRETERIATES (PROVIDED BY JFPMA)
13. AREAS OF ICH GIDELINES STABILITY.
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
15. Individual Harmonisation topics Safety.
16. Status of ICH GUIDE LINES: EFFICIENCY TOPICS