Additional guidance on the assessment on the risk ...

1/12 Active Pharmaceutical Ingredients Committee (APIC) Additional guidance on the assessment on the risk assessment for presence of N-nitrosamines in APIs 2/12 Table of contents 1. Introduction 2. Risk assessment guidance Prioritization of the risk assessment Management of raw materials in the risk assessment Risk assessment Content of risk assessment Boundaries of the risk assessment Methodology and outcome of the risk assessment Collaboration with customers Lifecycle of the risk assessment 3. Analytical Testing and Lifecycle Control Strategy Analytical Testing Control Strategy Lifecycle 4. References 5. Appendix 1 API Letter Report Template 3/12 Foreword This guidance document was prepared in 2020 by the APIC Nitrosamines Task Force on behalf of the Active Pharmaceutical Ingredient Committee (APIC) The Task Force members were: Porras Gustavo Afaquim Valls Jordi Afaquim Garcia Jordi Afaquim Camps Helena Afaquim Dobarro Alicia Afaquim Van De Velde Stefaan Ajinomoto Bio-Pharma Services van der Ven Jos Aspen Oss Fransen Gerrie Aspen Oss Slangen Peter Jan Aspen Oss Fendt Rainer BASF SE Becker Christian BASF SE Hudecek Torsten Boehringer Ingelheim Corpor

The API risk assessment should be reviewed and updated as applicable. - Use scientific knowledge or literature to obtain information (synthesis pathway, etc.) - Use alternative source of information (website, audit report…) 2.3. Risk assessment EFPIA decision tree [4] is a helpful tool to undertake the risk assessment.

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  Assessment, Guidance, Risks, Additional, Risk assessment, Additional guidance on the assessment

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