Search results for " control" in Articles / App Notes
Article
Evaluating Design Margin, Edge of Failure and Process
Two additional analyses are required to assure the chemistry, manufacturing, and control (CMC) team and associated health authorities all set points are safe with low out-of-specification (OOS) rates …
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Manufacturers Struggle with Breakthrough Drug Development
Chemistry, manufacturing, and control (CMC) issues are not considered at this point, although they are important for the product to come to market. Consequently, FDA officials urge manufacturers with …
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Brazil Emerges as Global Biopharm Collaborator
Brazil is also controlling the efficacy and safety of pharmaceutical products through market regulation.
According to Guimarães, considering government expenditures with health products, biophar…
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Supplier-Change Management for Drug-Product Manufacturers
This article provides an overview of the pharmaceutical SIC process, including a discussion on the need for control of SICs, a review of change notification scope and content, and a summary of how SIC…
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Report from India
(Dmitry Rukhlenko/Getty Images)
On July 1, India's new Drug Pricing Control Order (DPCO) 2013 replaced the 1995 version. Under this new regime, the National Pharmaceutical Pricing Pol…
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Advancing QbD in the EU
…ructured approach, which involves concepts like critical quality attributes (CQA), design space, and control strategies.
The industry has been urging EU authorities to put more emphasis in reg…
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Address the complexity of protein characterization
During development and quality control, you may use a range of analytical technologies to characterize biotherapeutic drugs in terms of their structural integrity and activity. This presentation inclu…
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In-person seminar: Manufacture of sterile medicinal products
Are you developing a Contamination Control Strategy? Join us for a free in-person seminar focused on applications at the end of the bulk drug substance workflow including drug product applicat…
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What is process development?
And if you make changes to your manufacturing process during clinical trials, this could impact regulatory CMC (chemistry, manufacturing, and controls) submissions and could have a negative effect on …
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
…dealing with the health authorities, or even the quality people or the chemistry, manufacturing, and controls (CMC) people. Know your process in the out and ensure that knowledge transfers across the…