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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.
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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 • 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)
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.
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.
For Isolating and Identifying process related Impurities using • MS • NMR • HPLC • FTICR-MS • LC-MS.
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.
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.
CO SPONSORS OF ICH. • EC-EU. • EFPIA. • MHW • JPMA • FDA • PRMA
FUNCTIONS. • 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. • 2.OBSERVERS: A.WHO B.EFTA C.HPB 3.SECRETERIATES (PROVIDED BY JFPMA)
AREAS OF ICH GIDELINES • STABILITY. • ANALYTICAL VALIDATION. • IMPURITIES. • PHARMACOPOEIAS. • BIOTECHNOLOGICAL QUALITY. • GMP. • TOXICITY. • KINETICS. • REPRODUCTIVE KINETICS. • CARCINOGENCITY.
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 • Safety. • Quality • Efficacy • Multidisciplinary
Status of ICH GUIDE LINES: EFFICIENCY TOPICS
Selection of Topics • Step 1 • Step 2 • Step 3 • Step 4 • Step 5