Direct Links to important GMP API Guidelines

Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations

This guidance provides FDA’s current thinking on determining sameness of human gene therapy products1 under FDA’s orphan drug regulations for the purpose of orphan-drug designation and orphan-drug exclusivity. This guidance is intended to assist stakeholders, including industry and academic sponsors who seek orphan-drug designation and orphan-drug exclusivity, in the development of gene therapies for rare diseases. This guidance focuses specifically on factors that FDA generally intends to consider when determining sameness for gene therapy products and does not address sameness determinations for other types of products.

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FDA Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs

This guidance recommends steps manufacturers of APIs and drug products should take to detectand prevent unacceptable levels of nitrosamine2 impurities in pharmaceutical products

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Commision Implementing Regulation (EU) 2021/1280 of 2 August 2021 as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the Europea

Good Distribution Practice for active substances used as starting materials in veterinary medicinal products

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GMP Conferences by Topics