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.
During my visit to Thailand, I was privy, not only to the particularly innovative research goals being pursued, but also to a number of challenges the country has recognized and hopes to address within the next few years to encourage a stronger, more diverse industry.
A few weeks ago, I was invited by the Thailand Board of Investment to attend a media trip to learn about the country’s budding life sciences industry. Entering Thailand, a country in which the government is pushing more investment and education in the sciences, was even more striking and meaningful to me given the current scientific climate in the U.S.
In the spirit of this list-making season, I compiled what I thought were the five most important biosimilar-related triumphs in the past year. Many of these events were widely covered by the media and will play an influential role in how the biosimilar industry unfolds through 2017 and beyond.
Pfizer's Bernie Huyghe and ADC Therapeutics' Michael Mulkerrin get bushwhacked with this question in a public forum. Their open replies will help each one of you to your own personal assessment. Be prepared for some soul searching.
Relocating an organization as large as the EMA, which employs upwards of 1,000 people in London, will be no easy feat. As such, IDA Ireland, an agency that supports companies in Ireland and promotes foreign direct investments in the country, is working to compile information on why Ireland would be a good location for the EMA.
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.
Water is the single largest quantity raw material used in pharmaceutical manufacturing. Water is used in all facets of manufacturing, from preparing equipment to manufacturing the final commercial product.
Critical control points for conventional aseptic processing are most often related to contamination resulting from human intervention and exposure of critical surfaces before and during fill. Extensive resources are required to install and maintain controls for these typical failure modes which can lead to two critical issues: shortages of essential medicines and inability to meet the timelines critical to control emerging pandemic threats.
Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This four-part article provides a foundational introduction to some of those aspects.
It seems blockchain technology is following the hype path the cloud did a few years ago. The most talked-about example of blockchain is Bitcoin, a digital currency that does not rely on a central authority (such as the Federal Reserve) to clear financial transactions. A few short months ago, the word “blockchain” was seldom mentioned in supply chain circles. Now, it’s not uncommon to be asked what your blockchain strategy is within those same circles. What has changed is its successful use and blockchain platforms adding functionality.
In this paper, we will detail the key functions of an energy-aware process automation system (PAS) and how its links between production and energy result in increased production and energy efficiency.
The mobile clean room is a self-contained manufacturing space fully constructed off-site. It is shipped to customer facility on a double drop flatbed trailer in one piece and ready to hook up.
There is a strong trend toward an increased patient-centric approach within the pharma industry. How will this trend drive the direction of cold chain for life sciences in the in the upcoming months and years?
Proper cleaning and maintenance of a tablet press and tooling is one of the easiest and most effective ways to ensure your press operates with optimum performance.
Global medicines use will reach 4.5 trillion doses by 2020, a 24 percent increase from 2015. According to the 2016 State of the Industry Report by PMMI, The Association for Packaging and Processing Technologies, the pharmaceutical industry will grow in kind and is expected to increase at a compound annual growth rate (CAGR) of 2.8 percent through 2020, constituting a faster growth rate than any other industry segment over that period.
The latest in automated lubrication systems ensure optimum equipment performance — even in demanding pharmaceutical manufacturing environments — and reduce unscheduled maintenance.
The humidity sensor is a small capacitor consisting of a hygroscopic dielectric material placed between a pair of electrodes.
