Search results for " regulators"
Article
FDA Framework Spurs Advanced Therapies
…n be built into the clinical development or commercial development plan, however, and discussed with regulators upfront,” Keene comments.
For some companies, however, a post-approval switch to…
Article
Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…
Article
Regulatory Challenges in the QbD Paradigm
Product specifications in the traditional approach are set based on process performance, and regulators expect them to be narrowed after enough process history has been established. On the other hand,…
Article
What's in Your SOP?
Writing SOPs to appease regulators or because you think the regulatory authorities require them will only lead to confusion and regulatory citations. Writing an SOP for a process, procedure, or operat…
Article
Biosimilars: Making the Switch Comes with Challenges
Biosimilar producers, regulators, and other key groups in the European healthcare sector, however, agree that the growth rate should be higher. This view was echoed by speakers at the annual Biosimila…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
“But the use of different definitions by companies for the same terms is something that should be sorted out between regulators.”
Some differences in terminology appear to have stemmed from comp…
Article
Using Software in Process Validation
Using Software in Process Validation
Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction.
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Article
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
“The company conducted a global trial in 20 countries with just 874 patients and clearly designed the study to optimize acceptance by regulators in several different countries around the world.” He ad…
Article
Driving Improved Access to Biosimilars
“I understand regulators’ and Congress’ urge to make biopharmaceuticals less expensive,” says Sheila Magil, managing director of the BioProcess Technology Group, part of BDO USA, who stresses that the…