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INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE GUIDELINE FOR ELEMENTAL IMPURITIES 元素杂质指南 Q3D Current Step 4 version dated 16 December 2014 This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Switzerland, Japan, USA and Canada.
Q3D Document History Code | | | | Approval by the Steering Committee under Step 2a. | | | Approval by the Steering Committee under Step 2b and release for public consultation. | | | Post sign-off corrigendum in: l Table 4.1 W and A1 were removed from the list of included elemental impurities in Class 2B and 3 respectively. l Table A2.1 the Class for Ni was changed to read 3 instead of 2 | | | Post sign-off minor editorial corrections including: removal of references to Appendix 5 (pgs i&13); deletion of redundant text (pg4); change of Option 2 to Option 2a(pg10); insertion of text under Safety Limiting Toxicity (pg35); reference to “metals” in text and “metal” in Table A4.7 title with “elementals” and “elements” (pg 73); and deletion of header Table A4.10 (pg75). | | | Addition of line numbers to facilitate the provision of comments by stakeholders. | | | Approval by the Steering Committee under Step 4 and recommendation for adoption to the ICH regulatory bodies. | |
Current Step 4 Version Code | | | | Corrigendum to correct: the modifying factor in the text of the safety assessment for Selenium (changed to 2 instead of 10 consistent with Section 3.1); and two references for consistency in the safety assessments for Barium (deleted reference ) and Vanadium (reviewed reference). | |
Legal notice: This document is protected by copyright and may be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that ICH's copyright in the document is acknowledged at all times. In case of any adaption, modification or translation of the document, reasonable steps must be taken to clearly label, demarcate or otherwise identify that changes were made to or based on the original document. Any impression that the adaption, modification or translation of the original document is endorsed or sponsored by the ICH must be avoided. The document is provided "as is" without warranty of any kind. In no event shall the ICH or the authors of the original document be liable for any claim, damages or other liability arising from the use of the document. The above-mentioned permissions do not apply to content supplied by third parties. Therefore, for documents where the copyright vests in a third party, permission for reproduction must be obtained from this copyright holder.
GUIDELINE FOR ELEMENTAL IMPURITIES ICH Harmonised Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 12 November 2014, this guideline is recommended for adoption to the regulatory parties to ICH.
TABLE OF CONTENTS | | | | | | 3. SAFETY ASSESSMENT OF POTENTIAL ELEMENTAL IMPURITIES | | 3.1 Principles of the Safety Assessment of Elemental Impurities for Oral, Parenteral and Inhalation Routes of Administration | | 3.2 Other Routes of Administration | | 3.3 Justification for Elemental Impurity Levels Higher than an Established PDE | | 3.4 Parenteral Products . | | 4. ELEMENT CLASSIFICATION | | 5. RISK ASSESSMENT AND CONTROL OF ELEMENTAL IMPURITIES | | | | 5.2 Potential Sources of Elemental Impurities | | 5.3 Identification of Potential Elemental Impurities | | 5.4 Recommendations for Elements to be Considered in the Risk Assessment | | | | 5.6 Summary of Risk Assessment Process | | 5.7 Special Considerations for Biotechnologically-Derived Products | | 6. CONTROL OF ELEMENTAL IMPURITIES | | 7. CONVERTING BETWEEN PDES AND CONCENTRATION LIMITS | | 8. SPECIATION AND OTHER CONSIDERATIONS | | | | | | | | | | Appendix 1: Method for Establishing Exposure Limits | | Appendix 2: Established PDEs for Elemental Impurities | | Appendix 3: Individual Safety Assessments | | Appendix 4: Illustrative Examples | |
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