Search results for " compliance"
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Setting Up Bioprocessing Systems for Digital Transformation
Bob Lenich, director of global life sciences at Emerson, says that manufacturers are well aware they will be audited, and thus recognize the need to have strict compliance in place. The challenge here…
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Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
This packaging method can improve overall process efficiency, regulatory compliance, and buffer quality.
A manufacturer should consider the powdered materials used in single-use delivery sy…
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The Evolving Role of Starting Materials in Cell and Gene Therapy
This provides the benefit of regulatory compliance and assured quality from the outset, while also avoiding the need to transport collected apheresis products to an off-site facility for preliminary c…
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Successfully Moving Regulated Data to the Cloud
FDA, Data Integrity and Compliance with Drug CGMP–Questions and Answers Guidance for Industry (CDER, December 2018).
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Navigating Data Integrity in the Modern Lab
The best way to ensure this consistency is by making it easier and less time-consuming to perform each routine activity, while passively recording each action for regulatory compliance. This can be ac…
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What's in Your SOP?
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
By S…
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Transformative Medicines Challenge FDA and Manufacturers
…perts explored strategies for tackling quality risk management, setting specifications, and assuring compliance with chemistry, manufacturing, and control (CMC) standards for experimental treatments.…
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Contract Manufacturing Through the Years
More recently, concerns about compliance problems at emerging-market API manufacturers have resulted in more opportunities going to North American and European manufacturers.
The robust en…
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Managing Residual Impurities During Downstream Processing
Ultimately the mission of SGS is to make sure everything we do can sustain scrutiny from any regulatory agency, both from scientific and compliance stand points,” Tissot explains.
To that end, SGS …
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Defining Risk Assessment of Aseptic Processes
FDA, Draft Guidance for Industry, Insanitary Conditions at Compounding Facilities (CDER Office of Compliance, August 2016).