The Quality Module (Module 3 or Chemistry, Manufacturing and, Controls section (CMC)) in the eCTD format serves as the backbone of any regulatory submission, an IND or NDA. We have discussed this in a previous blog posting. There is debate about the usefulness of the Quality Overall Summary (QOS or Module 2.3 of eCTD) with [...]
Archive for the 'CMC Issues' Category
Why have a Quality Overall Summary for the Quality Module?
Published October 5th, 2010 in CMC Issues and How to:. 0 CommentsTarget Product Profile
Published May 14th, 2010 in 505(b)(2) Process, CMC Issues and How to:. 0 CommentsToday’s blog courtesy of Lynn Gold, Ph.D. Camargo’s VP of CMC. In any project development program an understanding of the program goal is critical to finding the shortest path to the final result. Generation of a Target Product Profile early in a development program facilitates reaching the goal of a marketed drug product. It provides [...]
Several previous blogs have discussed the importance of maintaining quality oversight of a contract facility to the drug development timeline. Below is an example of a generic manufacturer with problems maintaining quality oversight of its own multiple sites. Apotex, the Canadian generic manufacturer received a CMC based warning letter on March 29th. This recent warning [...]
Manufacturing Problems for Intravenous Emulsions
Published April 23rd, 2010 in CMC Issues. 0 CommentsMany of the drug products manufactured by Hospira, including intravenous nutritional emulsions and propofol have been on the market for years. Hospira received a warning letter on April 12th citing two of its intravenous drug product manufacturing plants in North Carolina. The sites were inspected by the FDA in April 2009, and the violations cited [...]
Analytical Requirements for Oral Solutions
Published January 7th, 2010 in CMC Issues and How to:. 0 CommentsAnalytical requirements for the NDA submission of an oral solution to the FDA are very similar to those requirements for any new drug product. The analytical methods that are used for the testing of an oral solution at the NDA stage of development should be fully validated per the ICH guidelines, Q2A and Q2B, now [...]
Do not start the New Year off with CMC issues. Take the time to follow-up on your subcontractors before the FDA finds problems and delays submission approval. Pharmaxis Ltd. just found out the hard way that poor oversight of manufacturing and testing subcontractors will be a concern for the FDA. This concern translates into approval [...]
Comparability Protocols
Published September 10th, 2009 in 505(b)(2) Process and CMC Issues. 0 CommentsWhat do you need to do when you need to change suppliers or manufacturing sites? Among the many choices is a formal FDA Comparability Protocol. Our VP CMC, Lynn Gold explains. Advance planning can improve the possibility of FDA accepting your proposed change. One alternative that can streamline the process of change and add clarity to the requirements [...]
Test Specifications for Stability Studies
Published September 1st, 2009 in 505(b)(2) Process, CMC Issues, How to: and Outsourcing. 0 CommentsPivotal stability programs that are used to generate stability data for NDA submissions are different than research stability programs used to design the drug product, explore packaging configurations, etc. This is common sense, but we have seen instances of pivotal stability programs that have been performed for clients with no defined specifications. A stability protocol [...]
Linking Preclinical (Safety), Clinical (Efficacy) and CMC (Quality) Development Activities
Published June 26th, 2009 in 505(b)(2) Process and CMC Issues. 1 CommentCamargo is often called on to write and/or assemble NDAs. When we get to prepare an NDA from the beginning, all of the information builds and the resulting ‘story’ is easy for the FDA to understand. Often we are retained to write portions and just insert portions written by third parties. Gaps can ensue. Lyn [...]
FDA requests melamine testing of ingredients
Published August 7th, 2009 in CMC Issues, News Commentary and Uncategorized. 0 CommentsU. S. government officials both inside and outside of FDA have acknowledged that the Agency currently lacks the resources, both financial and human, to adequately monitor the materials going into products being used in the United States. The answer? In the case of the somewhat notorious contaminant melamine, the answer is to make regulated industry [...]