Direct Links to important GMP API Guidelines

API-Mix (or mixtures) and CEPs

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APIC - Guideline for the Establishment of a Control Procedure for Technical Equipment, including related Utilities, Computerised Systems and Facilities used in the Manufacture of APIs and Intermediates (revised Nov.2018)

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APIC - GMPs for APIs: "How to do" Document - Interpretation of the ICH Q7 Guide Version 15

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EU-GMP Leitfaden Teil 4: Leitlinien für die Gute Herstellungspraxis für Arzneimittel für neuartige Therapien (Advanced Therapy Medicinal Products, ATMPs)

ATMP Guidelines (in German language)

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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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GMP Conferences by Topics