Search results for " conference"
Article
Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
Because the non-EEA authorized product would have to follow similar scientific and regulatory standards as those of the EMA, it would have to be in a country that is a member of the International Conf…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
As the pharmaceutical industry tries to embrace the methodologies of quality by design (QbD) provided by the FDA’s process validation (PV) guidance (1) and International Conference on Harmonization (I…
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Biotechnology Innovation and Growth in Israel
In addition, Israel was one of the first countries to accept the International Conference on Harmonization (ICH) guidelines for good clinical practice (GCP), allowing for unified standards between the…
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State of Quality and Compliance in the Biopharmaceutical Industry
As a result of these efforts, new standards and guidelines have been published and numerous conferences held regarding quality systems, product quality, and regulatory compliance. However, after more …
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FDA Seeks Metrics to Define Drug Quality
…ouglas Stearn, deputy director for policy and analysis in CDER’s Office of Compliance, at the FDLI conference. Such standards could provide a look across a company and industry to better assess mater…
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Essentials in Establishing and Using Design Space
International Conference on Harmonization (ICH) Q8 (R2) 3.0 Glossary defines design space as follows (1):
“Design Space: The multidimensional combination and interaction of input variables (e.g.…
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Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
Report from the Lanzarote meeting May 13th – 17th, 2013
Yet another well-attended and successful Plasma Product Biotechnology (PPB) meeting has been held. The meeting focu…
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Essentials in Quality Risk Management
Quality risk management (QRM), as defined in International Conference on Harmonization's (ICH) Q9 document (1), is designed to ensure that drug critical quality attributes (CQAs) are defined and maint…
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Advancing QbD in the EU
EU authorities are stepping up their efforts to incorporate QbD principles.
The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD)…
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PDA's Technical Report for Biotech Cleaning Validation
Typically, validation involves principles from the International Conference on Harmonization's Q2 (R1) (4). Although degraded fragments of the active ingredient are measured in a cleaning-validation p…