Module 9 2021

Controls of materials – raw and starting materials

Two different types of materials enter in standard ATMP production process: ● Starting materials directly used in manufacture and intended to be part of the final product ● Raw materials: materials used in manufacture and not intended to be part of the final product Traceability: individual product and its starting and raw materials traceable through the sourcing, manufacturing, packaging, storage, transport and delivery. Data stored for a minimum of 30 years after product expiry The final user is responsible for the materials used, traceability and archiving

Novartis Pharma AG- Business use only- not for further distribution

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