Search results for " report"
Article
Efforts Accelerate to Streamline Postapproval Change Process
An International Council for Harmonization (ICH) expert working group (EWG) seeks to define those established conditions (ECs) that affect product quality and thus should be reported to regulatory aut…
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Framing Biopharma Success in 2016
John Jenkins, director of CDER’s Office on New Drugs, reported at the FDA/CMS Summit in December 2015 that manufacturing and inspections—not clinical development—are often the “rate-limited steps” for…
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Supplier-Change Management for Drug-Product Manufacturers
These systems should provide for reporting applicable changes to their pharmaceutical customers. These change notifications, when received, are evaluated to determine the impact on the manufacturing p…
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The Outlook for CMO Outsourcing in 2019
Also, lesser innovative classes of products are often outsourced; CMOs report a 15% increase in business in recent years from biosimilars projects.
Successful CMOs continually expand capacity a…
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Evaluating Surface Cleanliness Using a Risk-Based Approach
The reported recovery factor from a formulated alkaline cleaning agent, CIP 100 detergent, from 316 stainless steel was 93% (18).
Visual inspection
Visual inspection is important to ensure tha…
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The Metrics of Quality Culture
In some cases, the specified metrics are also reported to the agency via the annual report or are contained in the annual product review. The bio/pharma industry needs to review these metrics and ensu…
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Modern Manufacturing Systems Key to FDA Quality Initiative
At the same time, more transparent company reports on quality operations, market pressures to cut costs, and public demands for reliable patient access to critical therapies are combining to support a…
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A Look Ahead at BioPharma Manufacturing and Regulation
The overall effort builds upon the agency's Critical Path Initiative, launched in 2004, to drive innovation in scientific processes, which includes the 2011 report that prioritized eight areas, which …
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A Plastic Pipeline for Commercial Bioprocessing?
“Single-use systems work really well; once in a while you will find a glitch where it has been reported in the literature where certain cell types are a little slower in a bag system than in tradition…
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GMP Challenges for Advanced Therapy Medicinal Products
…ng a severe barrier to the development and delivery of [ATMP] medicines,” said AGORA in a progress report to the European Commission on its project (3). “[This is] weakening the position of the EU ac…