Since the publication of ICH Q9: Quality Risk Management in 2005 (1), there has been much written about the application of risk management to the production process, product development and validation (2–5). Relatively little has been published about its application to some of production’s supporting processes that comprise an important part of the pharmaceutical quality system (PQS).
A few months ago, I contributed an article on making GMP training more practical. In this article, we’ll expand on the topic and look at making GMP training more engaging and meaningful — to benefit both the business and its personnel.
Most combination products in the U.S. are reviewed primarily by FDA’s Center for Drug Evaluation and Research (CDER). Of these, many approvals occur via the “abbreviated” 505(b)(2) regulatory pathway. So, what is the 505(b)(2) pathway, and how can it save you time and money?
The newest round of Star Wars mania got me thinking about one of the themes in the movie series — mentoring.
“Closed system filling” is a new set of processing controls appropriate for a sterile filling process that eliminates potential microbiological contamination from environmental and operator sources through the use of closed systems. This is an automated sterile connector technology by which presterilized closed containers are filled through an engineered and controlled passage enabling the filled product, the internal container and the closure system surfaces to avoid exposure to the background environment.
While the development of a combination product comes with significant patient benefits through technology and molecule innovation, that reward can be offset by the range of regulatory complexity and uncertainty encountered with bringing a product to market, in addition to any post-marketing activities.
Incorporating wireless technology into medical devices is about more than just keeping up with the hottest technology trends; the benefits are real and significant, especially with regard to monitoring and encouraging dose compliance in the pharmaceutical and medical realm. Prior to embarking on the development of a wireless-enabled drug-delivery device, however, it is crucial to know what, specifically, the benefits are, and exactly what kinds of challenges and design considerations must be taken into account.
Many industry observers believe the need for responsive, collaborative, and tech-savvy partnerships is paramount in the new emerging business environment. Success or failure in this environment will be defined by operational agility to research, adapt, produce, and deliver products rapidly under fluctuating market conditions.
Since All I Really Need to Know I Learned in Kindergarten first appeared in 1988, its simple, profound wisdom has inspired the world. Among its easily digested messages are a few gems that research scientists would do well to employ in their labs every day: Share everything, Play fair, Put things back where you found them, CLEAN UP YOUR OWN MESS, Don't take things that aren't yours.
In this rapidly changing global economy, gray market diversion has become an ever increasing issue facing many brand owners today.
The Michael J. Fox Foundation (MJFF) is today announcing the launch of four new funding programs focused on driving forward research toward transformative treatments and a cure for Parkinson's disease (PD).
Artel is launching the first in a new line of 100% DMSO-based Sample Solutions for use with the MVS® Multichannel Verification System. These will provide users with the ability to measure the accuracy and precision of volumes of DMSO dispensed into microwell plates.
Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) today announced that the Company has initiated clinical trial sites and began enrolling patients in a Phase 3 clinical trial, known as PERSIST-1 or PAC325, for pacritinib, CTI's investigational JAK2 inhibitor, which is being evaluated for the treatment of patients with myelofibrosis.
Ambit Biosciences Inc. today announced that the company has closed the first $25 million tranche of a new $50 million preferred stock financing to support continued advancement of its lead drug candidate, quizartinib.
Sigma-Aldrich® Corporation (Nasdaq: SIAL) today announced that Sigma Advanced Genetic Engineering (SAGE) Labs, an initiative of Sigma®Life Science, and Ekam Imaging, Inc. have partnered to develop a suite of preclinical services based on the advanced translational power of genetically engineered rat models from SAGE Labs and Ekam's expertise in functional magnetic resonance imaging (fMRI) technology. For more information on SAGE Labs, visit www.sageresearchmodels.com
Bioanalytical and pharmacokinetic specialty Contract Research Organization (CRO) MicroConstants announced today the successful completion of a five-day inspection by the United States Food and Drug Administration (FDA) for compliance with Good Laboratory Practice (GLP) regulations.
QPS, LLC, a leading full-service GLP/GCP-compliant contract research organization providing testing services to support preclinical and clinical research and development, announced the acquisition of a majority interest in JSW Life Sciences GmbH. JSW provides preclinical and clinical Phase II – IV drug development services to pharmaceutical and biotech companies worldwide, and will be known as QPS JSW.
BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), today announced that the new BD MAX™ MRSA molecular test has received a Moderate Complexity rating under the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88). Performed on the fully-automated BD MAX™ System, the assay is designed to rapidly and accurately identify patients colonized with methicillin-resistant Staphylococcus aureus (MRSA).
Absorption Systems, a world leader in developing novel test systems for drug transporters, announces the availability of a long-awaited assay platform for the human BCRP transporter, also known as breast cancer resistance protein.