Module 9 2021

Raw materials - Risk based approach

Tier 1 – Low Risk: highly qualified material intended MP, MD or implantable device

Tier 2 – Low Risk: well characterized and intended as AM, GMP compliance

Tier 4 – High Risk: not intended as AM and non GMP compliance

Tier 3 – Moderate Risk: not intended as AM

Traceability Country of origin in respect of TSE

Upgrade to GMP production Internal Specifications Compatibility, cytotoxcity and Adventitious agents

Upgrade to GMP production Internal Specifications Compatibility, cytotoxcity and adventitious agents

DMF CoA Batch-to-batch performance CoA Confirmation Vendor Audit

CoA Confirmation Vendor Audit

DMF CoA Batch-to-batch performance CoA Confirmation Vendor Audit

DMF CoA Batch-to-batch performance

DMF CoA Batch-to-batch performance

Removal Stability

Removal Stability

Removal Stability

Removal Stability

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

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