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.
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.
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.
Failures in data governance and data integrity have been more prominent in health authority enforcement actions in the past few years. Health authorities review thousands of pages of data in original submissions and supplements covering the broad GxP area. Inspectors then review manufacturing and test data on-site during pre-approval inspections and routine GMP inspections.
Enhanced flexibility and reduced operating costs are being achieved through the widespread adoption of single-use technology either as part of completely single-use processes or as hybrid solutions.
Volumetric Imaging is the new technology platform developed by PTI to detect the integrity of pharmaceutical blister packaging non-destructively, with no specific tools or changeover required. This technology is the next generation of blister package inspection solutions, designed to replace the inaccurate and costly dye ingress methods.
Using QRM gives a company the ability to maintain compliance while also identifying product issues that could be harmful to the consumers, some being susceptible patients.
Proper cleaning and maintenance of a press is one of the easiest and most effective ways to ensure it operates with optimum performance. By Doug Kirsch, Technical Service Manager of Tablet Presses, Natoli Engineering Company
Here, we will discuss the costs and risks of taking a fragmented approach to managing and moving drug supplies and will explain how those risks can be mitigated.
Managing the integrity of manufacturing data is becoming ever more challenging, particularly as more and more critical manufacturing functions are outsourced, thus limiting the amount of oversight a pharmaceutical company can provide. Life science companies need to demonstrate control over their data—whether internally or externally generated. FDA officials indicate that “data that are not valid and trustworthy is a sign that an entire operation or facility is out of control and cannot assure the quality of its medicines”. Without accurate data, companies are less equipped to ensure the safety, effectiveness and quality of their products.
