Today, the FDA issued a draft guidance titled Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act (here). The various terms fall under the general areas identified in the DSCSA as Suspect Product and Illegitimate Product, and this guidance will help clarify how to further identify and […]
Have you ever wondered why, in many airports across different countries, there are multiple random security checks after the initial check at the entrance and before boarding the plane? Do all these intermediate checks make flying much safer? Are intermediate checks required because the initial check may not be trustworthy, or are they intended to […]
CDER has issued the final guidance, ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products, which provides for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM), applying to both drug substances and drug products for chemical entities, therapeutic proteins for new products, and conversion of existing products. A copy of the guidance […]
Hello from sunny Orlando and the AAM annual meeting! The FDA’s Jacqueline Corrigan-Curay, Principal Deputy Director, CDER, FDA, had the honor of providing the FDA’s keynote address. She started her talk by highlighting some of the accomplishments of GDUFA II, such as calling out the 490 first-generic approvals and 553 complex-generic approvals out of a total […]
Are your supply chain weaknesses putting patients at risk of not receiving safe, reliable medicines? This could be a difficult self-reflection for weak supply chains, devastated by the pandemic. The “race to the bottom” for cost and the cumulative effect of “lean-out” global supply chains have had an unintended consequence for the safe, reliable supply […]
The Food, Drug, and Cosmetic Act of 1938 was precipitated by a disaster where over 100 people died, many of whom were children. In the early 1930s, a wonder drug called sulfanilamide was marketed for treatment of certain infections. The problem with the drug was that it was very bitter, and, because of this, children […]
Is a mature pharmaceutical quality system really a competitive advantage? The industry held this as a belief, but progress in a tangible program was always elusive. On November 2nd, the CDER’s advisory committee, Pharmaceutical Science and Clinical Pharmacology Advisory Committee (PSCP‑AC), voted to establish a Quality Management Maturity (QMM) program to incentivize investments in mature […]
This year’s ISPE Annual Meeting and Expo in Orlando highlighted a number of key topics and trends in our industry’s digitization journey. These covered everything from industry progress with manufacturing and laboratory automation and digitization to trends in new technologies like blockchain and ways to modernize quality organization and systems to be digital future ready. […]
It is evident from reviewing recent health agency citations that the FDA expects that firms have a deep understanding of any systems that generate data/records and that this is reflected in the firm’s lifecycle management of those systems. What does that mean, in a practical sense? Well, a component of this understanding must extend to […]
Within the draft ICH Q14 “Analytical Procedure Development” guidance document (here), Section 6 refers to the Analytical Procedure Control Strategy. This should be developed prior to and confirmed via Analytical Method Validation. A key component of the Analytical Procedure Control Strategy is System Suitability (SST), but the guidance document also makes reference to sample suitability: […]
