The move to link inspectors to specific organizational units (i.e., drugs, devices, biologics) to more closely align with the Centers responsible for the products seems to have taken a turn back to a more generalist approach. According to a Pink Sheet article (here, subscription required) authored by Sarah Karlin-Smith and Derrick Gingery, the so-called “‘Simple […]
In the realm of pharmaceuticals, navigating the intricate landscape of facility and Quality Management System (QMS) remediation following FDA enforcement actions demands precision, foresight, and a commitment to sustainable change. When faced with regulatory scrutiny, it is imperative for companies to not only address the identified issues but also to comprehensively understand the root causes […]
The one-day event will explore how to achieve and maintain good relationships with your Contract Manufacturer Organisation (CMO) Partners. Key industry leaders will share their perspectives on many topics such as the selection of a service provider, regulatory trends, and how to foster collaborative synergies when outsourcing. Lachman Consultants (Ireland) provides a full range of […]
Earlier this year, the FDA issued a draft Guidance for Industry titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Guidance for Industry.” The proposed Guidance uses a risk-based approach based on product quality or facility-related risks and will be determined on a case-by-case basis by the FDA. Are you among the many […]
According to reports, the pharmaceutical job market has been expanding exponentially in recent months and is on an upward trajectory for job seekers. Occupational profiles are changing and many existing jobs, as a result of automation, are evolving, while completely new jobs are emerging. In this post-pandemic growth period, pharmaceutical companies are beginning to recognize […]
As U.S. consumers are facing critical drug shortages, leading Congress to question the FDA’s foreign inspection program, particularly for products with supply chains from India and China, the oversight of CGMP inspections is high on the Agency’s radar. With approximately 32% of generic drugs and 45% of active pharmaceutical ingredients (APIs) from these two countries, […]
It has been more than a year-and-a-half since the FDA released its publication “An update to the Resiliency Roadmap for FDA Inspections.” Are you among the many companies wanting to stay current and who can benefit from some assistance in creating an executable year-to-year plan to maintain both long and short-term inspection proactivity? If so, […]
Being proactive is always better than being reactive. And when it comes to a possible “visit” from FDA, anticipation and preparation go a long way in lowering anxiety and navigating the process successfully. Knock, knock. When an FDA investigator walks into your facility informing that they are going to conduct an inspection, a tense moment […]
The FDA exhibits a high degree of transparency in projecting its intentions and inspection plans. One has only to look at publications such as, “An update to the Resiliency Roadmap for FDA Inspections” (here) that was issued November 2021. So, one may ask, what has happened in the meantime and what is the plan for […]
In our previous installment on inspectional preparation and conduct, we covered recommended actions to be inspection ready, how to interact with FDA, and how personnel should conduct themselves during an FDA inspection. In today’s installment, we will cover what happens after the inspection, focusing on responding to an FDA 483 and inspectional outcome decision making. […]
