Active Pharmaceutical Ingredients Committee

APIC is the forum of producers of APIs and API intermediates in Europe.

APIC’s focus is on worldwide Quality, Good Manufacturing Practice (GMP) and Regulatory matters relating to APIs and intermediates. Through the years APIC has developed into a high-profile industry association with an excellent, worldwide reputation.
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Latest Publications

August 2024 - position_paper

APIC position on Nitrosamine Drug Substance Related Impurities (NDSRIs) and vulnerable amine impurities acceptable limits in APIs

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August 2024 - publication

Letter of intent for collaboration between APIs manufacturers ans MAHs on Nitrosamines Drug Substance

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April 2024 - publication

Annual Report 2023

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Pre-Conference Session “From theory to practice: implementing API Process Knowledge

Upcoming Event

Pre-Conference Session “From theory to practice: implementing API Process Knowledge

22.10.2024
Highlights Practical assistance and experiences how to implement API Process Knowledge from a quality and regulatory perspective of: Control Strategy Change Control Reprocessing and Rework...
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APIC 27th Annual API Conference

Upcoming Event

APIC 27th Annual API Conference

23.10.2024 - 24.10.2024
    Objectives of the Conference   The APIC/CEFIC Global GMP & Regulatory API Conference is Europe’s leading API event. Many major stakeholders from Authorities...
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ICH Q7 training week

Upcoming Event

ICH Q7 training week

18.11.2024 - 22.11.2024
These education courses have been developed to provide an excellent knowledge of the requirements laid down in ICH Q7. The contents of the guideline will be explained step by step and practical advic...
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