This article presents a detailed summary of the drug GMP warning letters issued in FY2017, as well as a comparison of trends since fiscal year 2013. A comprehensive GMP intelligence program includes evaluation of health authority enforcement actions, including FDA Forms 483, warning letters, seizures, recalls, and consent decree agreements.
Part 1 of this two-part article addressed FDA warning letter enforcement actions and discussed things that can go awry in these relationships related to data governance and data integrity. In Part 2, we turn our attention to health authority GMP guidance on contractual relationships and best practices that should be considered in this area.
Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system (QMS) is the integration of risk-based thinking. While the concepts of risk-based thinking and management are not new, previous practice was more reactionary, primarily focusing on detection after the fact, root cause analysis, corrective actions, and preventing recurrence of the failure. Contemporary thinking places the emphasis on considering risks up front (prevention) and having a solid approach to address risk in planning, managing, and driving actions.
If you are charged with any of the tasks that lead to a successful product launch in the pharmaceutical industry, you know how critical it is to execute a multitude of steps successfully. Among these are agreement by marketing on the look and design of the campaign, completion of clinical trials, project management, testing of active pharmaceutical ingredients, the completion of a trial production batch, receipt of all materials at the production site, production scheduling, regulatory agency submissions, trademark registration, and a host of others.
Our discussion continues with the physical application of GMP design practices as influenced by the CDC and NIH regulations. The first part of our design discussion covers various processes and their applicable BSL levels, to understand the risk levels and what types of processes must be contained.
In writing my last article about whether the life sciences industry has driven out people’s ability and motivation to think, I was reflecting on one of the most insightful comments I ever received. I had given a good manufacturing practice (GMP) refresher session in a company whose mantra was efficiency and speed. This led to a variety of process and cultural issues, because the desire for speed led to broken systems loaded with Band-Aids, corners being cut, people making mistakes, and more — which in turn created a poor quality culture within the company and led to deviations, scrap, and other problems.
A recently published article examining recent GMP inspection data from CDER (FDA’s Center for Drug Evaluation and Research) and MHRA (Medicines and Healthcare products Regulatory Agency) notes that “Deficiencies in investigations remains at the top of this list [of the most frequently cited observations] over the past four years. We as an industry cannot seem to get this quite right.” I agree.
Cleaning manufacturing equipment to prevent cross contamination of pharmaceutical products is a fundamental aspect of GMPs. Validation of cleaning processes has been required within cGMP industries for a long time and is recognized as an important activity to establish that product cross contamination is controlled to ensure patient safety and product quality.
India and China represent nearly 40 percent of the world’s population, so their domestic markets for biologics alone represent a remarkable opportunity. However, currently, the opportunities for sales of biological therapeutics remain in more developed countries.
Sponsor companies and contract manufacturing organizations (CMOs) have a lot to consider to develop a clear guide for how their organizations will work together effectively. In this article, practical considerations are explored in addition to the FDA’s updated guidance.