Artificial intelligence (AI), blockchain technology, predictive analytics, cloud computing, and speech and image recognition are the latest buzzwords across industries. Numerous companies are looking to inject these technologies into their operations, and a great deal of funding is pouring into related startups.
Probably one of the most significant developments in sterilization and aseptic practices in pharma is that of vaporized hydrogen peroxide (VHP) as a contact or “cold” sterilizing agent. The use of VHP in contained environments has allowed us to decontaminate working spaces, equipment, and materials and has led to the development of the reliable isolator.
The FDA recently issued for public comment six draft guidance documents intended to serve as part of a modern, comprehensive framework for how CBER will help advance the field of gene therapy. This is the third article in a six-part series.
The FDA inspected your firm, and one or more FDA Form 483 inspectional observations were noted by its team. This article provides guidance on how to minimize or avoid additional enforcement actions.
Contrary to how it sounds, controlling information is not about withholding key documents or facts that are relevant to the CMO bidding process to see how the bidders react, or only supplying pertinent information if requested. In fact, it is exactly the opposite is true.
A solid audit strategy and plan are critical to providing the highest degree of assurance that no data integrity breaches have occurred, short of 100% verification.
Glass breakage is commonly acknowledged as a major nuisance in parenteral manufacturing. It causes a plethora of problems, such as disruption of production, particle contamination and loss of sterility.
This is the first installment in a series of articles that will provide an overview of an area of potential interest to the readers of Pharmaceutical Online and Outsourced Pharma. By Mark Mitchnick, MD, and Robert W. Lee, PhD
Although the biosimilar space is still growing and evolving in the U.S., it is comparatively well-established in India. As such, the country can provide valuable lessons about what it takes to establish a thriving biosimilar market in terms of accessibility, competition, regulatory strategy, and other facets.
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