Data integrity and data quality are critical success factors for artificial intelligence (AI) and machine learning (ML) solutions in life sciences. Simply performing computer system validation or managing computer systems under CGMP conditions is not enough to ensure data integrity and data quality for data sets where AI/ML is intended to be applied.
Biopharma executives have warned they need more biologics development and manufacturing capacities, particularly in North America. They haven’t been howling at the moon. Four announcements – within two days of each other – offer a sign of relief. And Amgen has provided Outsourced Pharma with its first public estimate of costs for one of those facilities.
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.
Data integrity and data quality are critical success factors for artificial intelligence (AI) and machine learning (ML) solutions in life sciences. Simply performing computer system validation or managing computer systems under CGMP conditions is not enough to ensure data integrity and data quality for data sets where AI/ML is intended to be applied.
Measurable benefits of off-site module construction are becoming more evident, and it is emerging as a viable method for delivering a greater degree of predictability. Furthermore, market constraints driven by shortages of craft labor, lagging productivity, project complexity, and competitive forces are contributing to biopharma’s move toward modularization.
How can the industry improve the quality of its products? The first tactic could be to increase the frequency of vendor inspections, using internal quality control programs to inspect suppliers to assure compliance with the necessary supply agreements and adherence to appropriate manufacturing practices, including GMPs.
FDA enforcement for failures in data integrity and data governance began almost 20 years ago, and these areas remain as enforcement initiatives of the FDA and other global health authorities to this day. In 2018, however, we may have turned a corner.
In this sixth installment on the selection and use of quality improvement tools in your organization, Ben Locwin wraps up the series with a treatise on the 7 Tools of Quality.
This white paper presents some basic best practices for efficient processing in a Ribbon Blender. The ideas discussed here are recommendations based on practical and technical experience gained by Ross over several decades as a leading supplier of Ribbon Blenders to the process industries worldwide.
Lyophilization is a pivotal operation in the manufacture of solid-dosage drug forms. Because scale-up and technology transfer of the lyophilization process is challenging, it is important to develop a comprehensive understanding of critical lyophilization characteristics early on.
Learn how to employ science-, risk-, and statistics-based approaches to cleaning and cleaning validation at your facility with this free, 100-page e-book, written by a global team of cleaning validation experts, pharmaceutical toxicologists, statisticians, and Six Sigma professionals.
What can you do when the identification method defined by the USP monograph does not provide clear guidance? The authors decided to improve the method with a Quality by Design (QbD) approach.
Russian President V. Putin signed Federal Law No. 488-FZ, which deals with the amendments to the “Principles of State Regulation of Trading Activities in the Russian Federation”. This article outlines the labeling and management of track and trace data requirements of the new law.
A former FDA Biologics License Application reviewer and inspector focusing on microbiology, shares expert tips on how to best approach a bioburden problem when an FDA inspection is imminent.
Identifying the many factors that factor in when trying to obtain the perfect blend for your powder formulation.
In pharmaceutical formulating the elements are often not fully compatible and must be mixed following a strict procedure to obtain a stable and durable structure. This task is even more challenging when formulating with natural ingredients. The constant need to create new formulations or reformulate existing formulations requires thorough monitoring of formulation properties. This article outlines the crucial steps to be considered for a full and complete characterization of your formula.
