Search results for " guidelines" in Articles / App Notes
Article
Viral Clearance Challenges in Bioprocessing
“This practice is not in full compliance with current guidelines, but some agencies have accepted this type of data for IND applications of mAbs [monoclonal antibodies] derived from CHO [Chinese hamst…
Article
DoE Provides Benefits, but Preparation Is Necessary
In addition, a DoE-driven approach meets the International Conference on Harmonization Q8 guidelines for multivariate design space and the subsequent justification of formulation components when devel…
Article
Application of Quality by Design to Viral Safety
This approach uses the concepts laid out in the International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) guidelines, Q8 Pharmaceutical Development, Q9…
Article
Gowning Practices Provide Clues to cGMP Compliance
…eteria?
•Do you need to gown and de-gown just to get to a desired destination?
Regulatory guidelines for GMPs include straightforward statements, but the application of cGMPs to a facility i…
Article
Design of Experiments for Analytical Method Development and Validation
… was written in line with the International Conference of Harmonization (ICH) Q2(R1), Q8(R2), and Q9 guidelines (1-3). A quantitative understanding of the factors that influence resolution, linearity…
Article
FDA and EMA Extend QbD Parallel-Assessment Pilot Program
In the joint pilot program, which began in March 2011, FDA and EMA agreed to share knowledge, ensure consistent adherence to international guidelines related to QbD and promote the availability of pha…
Article
Best Practices in Adopting Single-Use Systems
At the most basic level, materials must meet stringent biological and chemical guidelines. Bioprocessors should settle for nothing less than fully compliant materials from proven suppliers with establ…
Article
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…
Article
FDA Seeks Metrics to Define Drug Quality
Manufacturing standards are considered key to preventing drug recalls and shortages.
Critical drug shortages and contaminated compounding of sterile injectables have heightened public concern a…
Article
Prescribing Caution for Biosimilars
…ns to switch to a different biologic drug, either at the pharmacy level or due to insurance coverage guidelines.
Until recently, there was no pathway for the development and approval of biosimila…