Preparing the Common Technical Document CTD for CMC

Regulatory bodies in the US, Canada, EU and Japan accept the CTD document format when applying for IND and NDA approval. This multiparty agreement, led by the ICH Harmonization, facilitates the application process when multi-nation regulatory approvals are being sought. The ground work and preparation of the CTD is critical since it serves as the platform for regulatory filings. Module 3 of the CTD focuses on Chemistry, Manufacturing and Controls (CMC) documentation relating to substance and product quality. Providing the correct information in sufficient detail in this section will reduce delays and costs.

D&MD's Preparing the Common Technical Document (CTD) for CMC provides a detailed description and analysis of the regulations, requirements and strategy for preparing a CTD. The focus is on the sections of Module 3 that demonstrate to "quality" of the candidate drug substance and product to the satisfaction of regulators. Getting this section right will save valuable time and subsequent effort since the CTD document is accepted by the regulatory bodies of the world's major pharmaceutical markets. This publication provides a review of the major steps as well as the current requirements for preparing the CTD document. This guide gives the reader a detailed breakdown of the steps involved and insights into what regulators look for. This guide also provides a detailed analysis of QC assay documentation and validation.

Published: February, 2007

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