Pharmaceutical Manufacturing QA/QC News Q3 2021
Trends and Industry News
- MHRA and US FDA tackle challenging data integrity
- ICH Q13: Release Guidance on Continuous Manufacturing of Drug Substances and Drug Products
- Current FDA Requirements for Cleaning Validation
- EDQM: Certification monthly report of activities: July 2021
- USP Opens Extended Public Comment Period for Revised Compounding Standards
Everything Comes Together to Say Quality
The Vehicle of Success - An Adaptive Approach to Genetic Medicines
Dr. Mansoor Amiji, University Distinguished Professor, Professor of Pharmaceutical Sciences and Professor of Chemical Engineering at Northeastern University, Boston, recently discussed the various approaches to gene therapy, including viral and non-viral vector delivery, and how regulatory agencies are ensuring these products are safe and effective for human use.
Limiting the Costs - the Multifarious Effects of Falsified and Substandard Medicines
There are ongoing global efforts to combat the dissemination of falsified and substandard medicines, which can pose a significant threat to public health and the product brand. Countering the problem of substandard medicines and adequately authenticating the end product presents numerous challenges for the regulators.
How to Simplify Your Tablet Analysis
Recent advances in Near-Infrared spectroscopy have changed the ways in which both the pharmaceutical industry and the regulators view the current approaches to tablet testing.
The use of NIR transmission for whole tablet analysis can effectively improve the efficiency of the tablet pressing step by allowing faster feedback into the process than the conventional HPLC method.
Never Miss a Peak in Your QC Lab
Whatever your separation challenge, your choice of liquid chromatography column can make all the difference. Our portfolio of LC columns allows you to achieve rugged and reproducible results – batch to batch and column to column – with an all-encompassing, flexible solution that meets the diverse, changing needs of analysis.
Read more by clicking on API name below: