February 28, 2020
Looking for answers? Where are you at with your process and controls? Who is managing the operations? What bioassays are necessary for your product? When, where and how to validate your bioassay?
U S Food and Drug Administration
March 30, 2020
e FDA recognizes that CMC-specific discussions, during Pre-IND meetings, are typically unnecessary when projects are “straightforward.” However, unlike more traditional 505(b)(2) products, certain new chemical entities (NCE’s) and biologics are anything but straightforward. These novelties can create unique manufacturing roadblocks that impede the path to clinical development.
May 7, 2020
With reduced resources accessible (both in personnel and funding), smaller emerging sponsors will seldom have a sizable Chemistry, Manufacturing and Controls (CMC) group, and in many cases may only have one support individual within their organization. It is common for all CMC activities from pre-IND through Phase 2 and even beyond to be coordinated by this one individual, often simultaneously with other responsibilities. Most if not all these sponsors, who in many cases are also virtual, use contract manufacturing organizations (CMOs) for the CMC aspects of their development and manufacturing.
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.