Chemistry, Manufacturing and Controls (CMC) Technical Writing

The CMC information is included in the CTD in Module 2.3 Quality Overall Summary (QOS) and Module 3. These modules are typically structured logically and systematically with comprehensive information about the development, manufacturing, and quality control of the pharmaceutical product. The structure is defined in the ICH guidance M4Q. Information on the drug substance and drug product is split into separate branches, and each branch roughly contains information on the following topics: composition, manufacturing process, control, reference materials, packaging material, and stability.

n general, the required information for an IND/IMPD is less detailed, acknowledging ongoing development and optimization. Certain information is allowed to be preliminary or high-level. The focus is on critical information required to ensure participant safety and preliminary product quality. For an MAA/BLA, the CMC part should include extensive validation and justification for all aspects of the manufacturing process and controls.

If you have specific questions about these differences or require guidance, don’t hesitate to reach out to us.

The Quality Overall Summary (QOS) serves as a comprehensive overview of the quality-related information included in a drug product dossier. The primary function of Module 2.3 is to provide regulatory authorities with a summary of the quality data, assessments, and conclusions related to the pharmaceutical product.

It might seem appealing to include as many details as possible in your documents, to try to avoid questions from health authorities. However, including too much detail is generally not beneficial. Regulatory reviewers might not appreciate elaborations or unnecessary information. This can in fact raise more questions. Another downside of using extensive detail is the need to update your file by means of post-approval variations for every small change in the future.

Finding the optimal balance in the level of detail is one of the most challenging aspects of CMC technical writing. Being transparent and fulfilling the regulatory requirements is key, however ensuring the information is relevant, accurate, and organized in a clear and concise manner greatly facilitates regulatory review and approval.

If you do not have the appropriate knowledge for finding this balance, calling in assistance from an experienced regulatory consultant like Starodub can avoid unnecessary delays and speed up the regulatory approval.