Assessment of the Equivalence of Technical Materials - European ...

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A.8 METHOD OR METHODS OF MANUFACTURE (ANNEX IIA 1.8)XXXXXXXXXA.9 SPECIFICATION OF PURITY OF THE ACTIVE SUBSTANCE (ANNEX IIA 1.9)Minimum purity:A.10 IDENTITY OF ISOMERS, IMPURITIES AND ADDITIVES (ANNEX IIA 1.10)XXXXXXA.11 ANALYTICAL PROFILE OF BATCHES (ANNEX IIA 1.11)XXXXXXSECTION B: ANALYTICAL METHODSB.1 ANALYTICAL METHODS FOR THE DETERMINATION OF PURE ACTIVESUBSTANCE IN THE ACTIVE SUBSTANCE AS MANUFACTURED(ANNEX IIA 4.1.1)Specificity:XXXXXXLinearity:XXXXXXAccuracy:XXXXXXPrecisionXXXXXXB.2 ANALYTICAL METHODS FOR THE DETERMINATION OF SIGNIFICANTAND/OR RELEVANT IMPURITIES IN THE ACTIVE SUBSTANCE ASMANUFACTURED (ANNEX IIA 4.1.2)Specificity:XXXXXXLinearity:34
XXXXXXAccuracy:XXXXXXPrecisionXXXXXX3. TIER I: EVALUATION OF CHEMICAL EQUIVALENCE1. ASSESSMENT OF CHEMICAL EQUIVALENCEActive substanceImpurity 1Impurity 2Impurity 3…Reference source(clearly defined, incases where morethan one exists)Certified valuesDifferent SourceCertified valuesVariation2. CONCLUSIONS AND RECOMMENDATIONSInclude consideration of need for Tier II assessment.4 TIER II: TOXICOLOGY & ECOTOXICOLOGY1. ASSESSMENT OF EQUIVALENCE2. CONCLUSIONS AND RECOMMENDATIONS5. OVERALL CONCLUSION ON EQUIVALENCEGive details of reference source, including location (e.g. DAR) and summaryof TIER I and TIER II assessmentTechnical material equivalent following Tier I assessment?Technical material equivalent following Tier II assessment?35
Page 1 and 2: EUROPEAN COMMISSIONHEALTH AND CONSU
Page 3 and 4: 1 Implementing scheduleThis amended
Page 5 and 6: Significant impuritiesImpurities th
Page 7 and 8: 7.1.2 Evaluation processThe objecti
Page 9 and 10: If the answer is yes, it might be a
Page 11 and 12: a) Prediction of the expected incre
Page 13 and 14: Bridging across different media (e.
Page 15 and 16: Loewe, S, Muischnek, H. (1926). Üb
Page 17 and 18: 1. Ascertainment of the necessity t
Page 19 and 20: Appendix Ib: Evaluation and decisio
Page 21 and 22: Appendix III, which is based on a l
Page 23 and 24: tests with information provided on
Page 25 and 26: Appendix IV Guideline triggers for
Page 27 and 28: Appendix V How to judge what is an
Page 29 and 30: Appendix VI Example calculations fo
Page 31 and 32: TABLE OF CONTENTS1 STATEMENT OF THE
Page 33: A.4 MANUFACTURER’S DEVELOPMENT CO
Page 37: SUMMARY OF THE TECHNICAL EQUIVALENC

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