How can the industry improve the quality of its products? The first tactic could be for the industry 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.
Welcome to the sixth and final installment of this series on the proper selection and use of tools to help you improve Quality within your organization. This article ties together the previous five in this series with a treatise on the 7 Tools of Quality.
While many may conceptually understand change control for equipment and facilities, most lack the knowledge to apply this control to highly sophisticated equipment and the utilities to which they connect.
Microbial data deviation investigations are notoriously difficult to perform. They are time consuming and labor intensive. Determining the definitive root cause is often challenging. Evidence to support conclusions and decisions takes time to collect, and the available evidence is usually circumstantial and often scanty.
Adapting any manufacturing process to continuous manufacturing requires in-depth chemical and mechanical engineering understanding as well as the right technologies.
Respiratory diseases are an appealing target for future microbiome development, with the combined asthma and chronic obstructive pulmonary disease (COPD) market approaching $30 billion by 2020 in the U.S. alone, and with significant unmet needs remaining in both markets.
Why does “Quality” seem like such a slippery, elusive term? The answer is easy: It’s because the people who claim to know it really don’t. And everyone seems to go along with the rhetoric.
BPO, benzyl peroxide, a compound that has both a fuel source and oxygen (two legs of the fire triangle) built into it, can make handling of a purified version of this compound very interesting.
It will be increasingly important for biopharma companies to employ ingenious strategies to access data already existing in the healthcare environment, moving away from solely building and owning data sets.
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