Regulatory Odd Couple Series
May 21, 2020
Module 3 is a well defined component of the Common Technical Document (CTD) containing both drug substance (active ingredient) and drug product sections, each containing required presentations of Chemistry, Manufacturing and Controls (CMC) information, covering processes and key control parameters, and various justifications supported by qualification and validation studies.
June 2, 2020
The value of the QOS should be to point reviewers at the most important information to support the quality of the drug in the most transparent presentation possible.
June 12, 2020
For the purposes of this blog series, it will be necessary to produce an admittedly unbalanced summary that shortchanges some sections of the Quality Module but that includes considerable discussion of other sections that can largely influence the ultimate success or failure of an application. I have therefore focused discussion on selected aspects from a remarkably diverse and technical exercise, which is the production of the CTD Quality Module.
June 23, 2020
An overview of the quality assurance aspects of the manufacturers may provide insight into the viability of the process. Although not required to be included in the application, a request for the report of the most recent cGMP manufacturing inspection from the US Food and Drug Administration (FDA) and/or European Union (EU) agencies enable a broad overview of the cGMP compliance aspects of the facilities.
July 2, 2020
The acceptance criteria and tests conducted for the excipients should be reviewed relative to the preformulation experimental results. The acceptance criteria for the excipients should consider those qualities critical to the drug product performance and manufacturing operation as described earlier in formulation development.
July 14, 2020
Perhaps the most consequential specification input is analytical method capability. The attribute of interest must, after all, be assessable. Thus specifications depend on the method’s specificity, sensitivity, variability, and accuracy.