Search results for " Lifecycle"
Article
Best Practices in Adopting Single-Use Systems
Suppliers should be prepared to play an ongoing support role for every single-use system sale, and for the product’s entire lifecycle. End-users should ask for specific examples of a proposed vendor’s…
Article
Implementing QbD in Sterile Manufacturing
Even if challenges as previously described appear in the early stages, the gained knowledge will likely result in an economic benefit in the long-term commercial lifecycle.
Benefits of QbD
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Essentials in Quality Risk Management
Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.
Quality risk management (QRM), as defined in Internatio…
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
The deliverables associated with the product lifecycle are more robust and timely. Additionally, the long-term support through the CPV program is optimal and flexible. As shown in Figure 1, the advant…
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Advancing QbD in the EU
These guidelines cover pharmaceutical development concepts in Q8, quality risk management (QRM) in Q9, and a pharmaceutical quality system to be implemented in the different stages of a product lifecy…
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A Look Ahead at BioPharma Manufacturing and Regulation
By granting FDA new authorities that more accurately reflect the entire drug lifecycle, FDASIA better equips the agency to protect public health and minimize consumer exposure to unsafe, ineffective, …