Use of environmental isolates in the pharmaceutical microbiology laboratory has been increasing in popularity, and, in some instances, warning letters have been written for not using environmental isolates in microbiological testing. However, because the available regulations and guidance documents are not clear regarding the use of environmental isolates, opinions vary on how to use them appropriately. This article discusses the current guidance documents, regulatory expectations, and expert opinions on the use of environmental isolates.
The next stage in maintenance management, Maintenance 4.0, is to go beyond predictive to the initial stage of an asset — commissioning the assets and deploying the same tools and techniques to set the measures within the design specification from the beginning onward, and using indicative measures to keep the asset in its original design specification.
Cell, gene, and other emerging therapies are distinctly different from traditional biopharma products. Every lot is for a named patient or small population of patients, and that lot drives direct uplift on the bottom line. Traditional supply chain management does not necessarily create patient value in emerging therapy value chains. Operations should be the backbone of a distribution model that delivers these products efficiently and effectively over the last few yards.
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.
The number of new chemical entities gaining FDA approval more than doubled from 2017 to 2018. Global R&D spending increased 3.5%. The pipeline is strong, but how many innovations are actually reaching patients?
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.
Upstream bioprocessing at large and commercial scales is projected to be the fastest growing segment of the single-use equipment market as products now in development using SUS move up to commercial manufacturing. In addition, as cellular and gene therapies emerge, we will likely see SUS technologies created and adapted explicitly for these personalized applications.
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.
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