Chemically Synthesized APIs - CTD and GMP Aspects MasterClass - US edition

The MasterClass will provide an updated overview on GMP-, as well as CTD requirements related to small molecule APIs.

06-07 May, 2025, Virtual

Time Zone: Eastern Daylight Time (EDT)- UTC04:00

Overview

Most drug product manufacturers do not synthetise commercial API quantities in their own facilities, they purchase it from external sources. Due to global supply chains, specific challenges with respect to import regulations and global communication will have to be taken into account. It is essential to understand the regulatory requirements in the EU in order to be prepared for negotiations with global API manufacturers.

To compile the CTD module 3.2.S, detailed descriptions of the synthesis development and the manufacturing process of an API are required. The release specification, including impurities from specific synthesis procedures has to be justified in the relevant CTD sections.

There is a conflict of interest between the detailed information required by the regulatory authorities and the API manufacturers who need to protect their proprietary know how. This conflict can be solved by using the European ASMF or CEP procedures. The drug product manufacturer should be aware of the limitations of both procedures, however, to be prepared to request essential GMP and CMC documents from the API manufacturer.

The company holding the marketing authorisation and releasing the drug product for the market is ultimately responsible for all aspects of the drug product, including the API.

The MasterClass will provide an updated overview on GMP-, as well as CTD requirements related to small molecule APIs.

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RECOMMENDATION

Who should attend?

Heads of R&D
Heads of API development
Heads of QC
QA Heads
Heads of drug regulatory affairs
Pharmaceutical development managers
API synthesis chemists
Regulatory affairs managers
Stability control managers
QC managers
Purchasing managers