Search results for " guideline"
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
EMA, Guideline on the Use of Bovine Serum in the Manufacture of Human Biological Medicinal Products (London, May 30, 2013).
2. EMA, Requirements and Controls Applied to Bovine Serum Us…
Article
The Metrics of Quality Culture
…
After a few years of actively engaging and listening to industry in a variety of venues, this new guideline has finally been released.
The metrics proposed in the guideline are not new to the …
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
In 2013, the agency also issued a draft concept paper on the comparison of biosimilars with reference products; the similarity guidelines and clinical and non-clinical requirements were updated, and a…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
ICH, Q8(R2) Harmonized Tripartite Guideline, Pharmaceutical Development, Step 4 version (August 2009).
3. ICH, Q9 Harmonized Tripartite Guideline, Quality Risk Management (June 2006).
4. ICH, …
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
ICH, Q8(R2) Harmonized Tripartite Guideline, Pharmaceutical Development, Step 4 version (August 2009).
3. ICH, Q9 Harmonized Tripartite Guideline, Quality Risk Management (June 2006).
4. ICH, …
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
ICH, Q8(R2) Harmonized Tripartite Guideline, Pharmaceutical Development, Step 4 version (August 2009).
3. ICH, Q9 Harmonized Tripartite Guideline, Quality Risk Management (June 2006).
4. ICH, …
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
…or protein characterization studies, and these methods can be readily validated following regulatory guidelines. Further technological advancements in sample preparation throughput and data handling …
Article
Quality by design for biotechnology products—part 1
… John Towns
ABSTRACT
The International Conference on Harmonization (ICH) Q8(R2), Q9, and Q10 guidelines provide the foundation for implementing Quality by Design (QbD). Applying those concept…
Article
Mechanistic vs Statistical Models
Mathematical models are recommended by the ICH Q8 guidelines on pharmaceutical development to generate enhanced process understanding and meet Quality-by-Design (QbD) guidelines. Read on the d…
Article
Reimagining Affordable Biosimilars
Concepts of “totality of evidence (ToE)” and “confirmation of sufficient likeness (CSL)” have been added and more recently edited from the regulatory guidelines (29,30).
Regulatory changes have …