CMC Support

CMC is short for Chemistry, Manufacturing and Control and covers all manufacturing- and testing-related work in drug development. In the CTD (Common Technical Document), it corresponds to CTD 2.3 (summary) and CTD 3 (quality). From the development stage onward, the drug's critical quality attributes (CQAs), specifications and test methods, and manufacturing method must be properly examined. If they are not, and the properties or quality of the test article vary widely, the reliability of nonclinical study and clinical trial results can be seriously affected.

The Pharmaceuticals and Medical Devices Agency (PMDA) conducts its review based on the application data, but the data itself must be accurate and reliable, so a reliability inspection of the application data is conducted separately from the review. Reliability is governed by the GLP Ordinance, the GCP Ordinance and the Enforcement Regulations of the PMD Act, which are collectively called the reliability standards.

Taking a nonclinical pharmacology study as an example, records such as the following must be kept:

• Can everyone who performed the experiments be identified?
• Is the raw data, on paper and electronic, retained and available for reference rather than discarded?
• Are the names and lot numbers of the reagents used recorded?
• Is the manufacturing method of the test article recorded, so that it is clear later how it was made?

The Common Technical Document (CTD) is the technical documentation attached to an application for marketing approval. Application data must be collected and prepared in accordance with the reliability standards.