Raw and starting materials Sample Clauses

Raw and starting materials. If raw materials and process aids are procured by Unigene, and such material becomes part of the API or comes into contact with the API (or with its precursors) during its manufacture, Unigene ensures and certifies that their quality is in compliance with the current TSE Guideline (Note for Guidance on minimising the risk of transmitting spongiform encephalopathy agents via human and veterinary medicinal products (EMEA/410/01, Rev. 2 or applicable update). This also applies to raw materials and process aids used before the synthesis of the Active Pharmaceutical Ingredient Starting Material (API-SM). The Novartis TSE Questionnaire templates (see Enclosure D) are provided to outline the requirements and are the basis for an assessment of TSE safety. Unigene is expected to ensure that it is completed: • either for each batch of each material used throughout the entire synthesis or that comes into contact with the API (e.g. cleaning material, primary packaging material) • or – in case that only product-specific TSE statements are available for such a material—that a valid change control statement (see Enclosure D, questionnaire on page 1) is included in such statement. Novartis reserves the right to audit (for Quality purposes) or request copies (for Regulatory purposes) of any or all questionnaires of material used during the synthesis or primary packaging of the API. Novartis acknowledges and consents to limiting access of this information on a “need-to-know” basis only. Furthermore, a TSE compliance statement (see template, Enclosure E) shall be provided to Novartis for each batch of the API, signed by the Quality Assurance Unit of Unigene. For authorities asking for more information (e.g., Japan), Unigene shall readily provide the documentation needed or promptly request information from its vendors. Upon receipt of starting materials for Manufacturing, the shipping containers must be checked by Unigene for: Completeness and accuracy of material shipment External condition Intact and authentic seal Identity of material Unigene must maintain records of each batch of starting material used in Manufacturing consisting of quantity delivered, usage of each batch, and investigation into any discrepancy. If Novartis orders starting materials for use in Manufacturing, Unigene is responsible for testing and release of material according to agreed upon test methods and specifications, as specified by Novartis. If not specified, Unigene will be responsible for test m...
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Raw and starting materials 
Sample 1

Related to Raw and starting materials

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