Project execution and project management are probably two of the topics that are most written about but least understood by the biopharmaceutical industry. This article is not about the theory of management, but it is a primer on approaches to project execution, some of which may assist the reader in understanding their path of least risk.
Every organization that is regulated by the FDA must consider sources of contamination and cross-contamination in their manufacturing operations. A robust personnel hygiene program is an important element for good manufacturing practices (GMPs) necessary to prevent contamination and cross-contamination, in order to ensure the safety of medicinal products.
Of the four critical documents that must be negotiated and executed by both sponsor and CDMO (NDA, quotation, MSA/SA, and QTA), the QTA is often the least-prioritized by the procurement team. Yet, in practice, the QTA will be the most useful for development- and clinical-stage companies, because it provides a framework for operations and a road map for building quality systems.
From “serialization” to “coding” to “track-and-trace,” the pharmaceutical industry is rampant with terms that point to the quest for transparency. The latest of these is “aggregation,” a burgeoning method of data collection aimed at simplifying inventory and the supply chain. While still in its infancy, the technique can help to combat counterfeiting, theft, inefficiencies, and confusion as a whole. Yet, with every new process comes challenges, requiring manufacturers considering aggregation to seek best practices for implementation.
Though the FDA has laid down clear steps for abbreviated new drug application (ANDA) submissions, applicants still struggle with the procedural challenges in preparing and submitting their applications. As such, it is important to dig deeper into the process and understand the possible reasons why the FDA may refuse to approve — or even refuse to receive (RTR) — an ANDA submission.
The majority of biologic products today are launched as some form of combination product, stringently regulated by the FDA through 21 CFR Part 4. This article looks at important manufacturing, packaging, and other factors that developers of combination products must consider and why they need to be considered early in the device development program.
Understanding how to be appropriately staffed and being prepared to explain any perception of inequity could mean the difference between success and failure of appropriate data integrity in both regulatory compliance and product support.
Overall, the growth in Asia’s bioprocessing capacity, particularly in China, has been impressive, albeit from a low baseline. Capacity growth over the past five years has been over 20 percent annually. New facility construction and expansions reflect the demand for biologics for domestic consumption, while other facilities are beginning to develop manufacturing strategies for GMP production for major markets, with capacity involving commercial-scale stainless steel and single-use bioreactors.
Virtual pharmaceutical/biotech companies often receive conflicting advice regarding the need to establish an internal cGMP quality system. Either they’re told “you need an extensive set of cGMP SOPs” or “you don’t need any cGMP SOPs at all.” Which advice is correct?
This is Part 1 of a two-part article discussing important areas to consider when developing devices for combination products — and why they need to be addressed early in development. In this installment, we will look at the areas of primary container, device development, device selection, and design control.
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