Search results for " regulations"
Article
FDA Framework Spurs Advanced Therapies
In addition, because Lonza takes a science-based approach to the development of advanced therapy medicinal products (ATMPs) while at the same time evaluating risk, the new regulations lay the groundwo…
Article
Understanding Validation and Technical Transfer, Part I
…osmetic Act, which among other provisions, authorized FDA to issue good manufacturing practice (GMP) regulations for “manufacturing, packaging, or holding of finished pharmaceuticals.” Those regulati…
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Regulatory Challenges in the QbD Paradigm
CURRENT REGULATIONS AND COMPARABILITY PROTOCOLS
An overview of current FDA regulations and guidance is helpful to discover hidden opportunities and how they can be leveraged for the QbD paradigm f…
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What's in Your SOP?
SOPs are useful tools for operationalizing, optimizing, and communicating important corporate policies, government regulations, and best practices for ensuring consistent, reliable, and safe medicatio…
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Biosimilars: Making the Switch Comes with Challenges
More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.
By Sean Milmo
The use o…
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Quality by Design—Bridging the Gap between Concept and Implementation
The drive to embed quality-by-design (QbD) principles into the pharmaceutical regulatory framework of the European Union has reached a key point 10 years after the European Medicines Agency (EMA) firs…
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Using Software in Process Validation
These regulations state that manufacturing processes must be designed and controlled to ensure that in-process materials and the finished product comply with quality requirements that have already bee…
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GMP Challenges for Advanced Therapy Medicinal Products
Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.
By Sean Milmo
A consultation period…
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
… one candidate, including the necessary mammalian cell culture facility built in compliance with GMP regulations and a highly educated and experienced workforce, according to Kim. “Since 2002, we hav…
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Driving Improved Access to Biosimilars
In June, FDA also issued clarification and a proposed revision to regulations that have not allowed biosimilar developers to refer to drug master files (DMFs) in applications (15). The proposed rule, …