Search results for " control"
Article
Best Practices in Qualification of Single-Use Systems
• “Processing aids, hazardous or highly toxic raw materials, other special materials, or materials transferred to another unit within the company’s control do not need to be tested if the manufacturer…
Article
Fluid Handling in Biopharma Facilities
The fluid handling process will be defined by regulatory compliance, economics, safety, sterilization, risk management, process control, automation, productivity, cleanliness, and flexibility. For exa…
Article
Robust Optimization, Simulation, and Effective Design Space
Define the effective design space used for process control and define the purpose of the design space.
Steps 7–12 will be discussed in detail in this paper.
Figure 1: Robust optimization…
Article
Quality Systems Key to Lifecycle Drug Management
FDA officials have long proposed that manufacturers implementing quality-by-design (QbD) approaches and quality controls should be able to manage postapproval changes with less regulatory oversight. T…
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Re-use of Protein A Resin: Fouling and Economics
The controlled pore glass-based Protein A resin from EMD Millipore (ProSep) has better flow characteristics and diffusional properties than agarose-based Protein A resins (13). However, it suffers fro…
Article
Challenges and Trends in Biopharma Facility Design
Quality control and building standards are also essential, with a view to meeting [European Medicines Agency] EMA, FDA, [Chinese Food and Drug Administration] CFDA, and other regulatory standards for …
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 …
Article
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 …
Article
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…
Article
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…