Search results for " GMP"
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Continued Process Verification for Biopharma Manufacturing
Some elements of CPV overlap with existing GMP systems such as the generation of data for batch release (BR) decisions, annual product review (APR), and change control.
In general, the nature and …
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FDA Seeks Metrics to Define Drug Quality
FDA is seeking new strategies to spur compliance with GMPs and to limit drug production errors that lead to supply problems, Woodcock explained at a July 10, 2013 seminar on “Understanding cGMPs” spon…
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Announcing ÄKTA ready™ extended single-use system
ÄKTA ready™ extended system is a single-use liquid chromatography system designed for process scale-up and GMP manufacturing.
The system uses disposable flow paths and prepacked …
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Innovative Chromatography Resins Can Improve Purity and Quality
The underlying affinity ligand molecule plays a critical role in the performance required for clinical and commercial GMP [good manufacturing practice] manufacturing,” he adds.
Schub notes that ex…
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Biomanufacturing: Demand for Continuous Bioprocessing Increasing
Biomanufacturing: Demand for Continuous Bioprocessing Increasing
But are innovations sufficient to increase adoption? CMOs are demanding better continuous bioprocessing options. …
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Science Focus Fuels Successful Process Development for Startups
“We built a GMP facility to manufacture the products entirely in-house, so process development was a fundamental activity for us,” she adds.
In-house or outsource?
The decision to build its ow…
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The Challenge of Disruptive Technologies in Bioprocessing
Customers are demanding overall efficient, cost-effective solutions, faster, just-in-time service and delivery, supply chain logistics, full [good manufacturing practice] GMP documentation, high consi…
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Process Development: What May Lie Ahead in 2018?
Surely, this strategy will remain viable in 2018 and onward as firms strive to remain one step ahead in process development and prepare for later-stage GMP work.
Scientific Advancements
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Transformative Medicines Challenge FDA and Manufacturers
FDA officials say they are open to considering alternative proposals from manufacturers for GMP compliance and advise firms to indicate clearly in submissions how multiple facilities aim to achieve st…
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Best Practices for Data Integrity
If manufacturing data are missing or inaccurate, then the firm is in violation of GMP regulations; it may mean that the quality of the product cannot be trusted. In serious cases, bad data integrity c…