Importance of sublimation tests when freeze-drying HPAPIs shown in study
Researchers have shown that sublimation tests should be conducted if new components are added to the freeze-drying process of HPAPIs.
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Researchers have shown that sublimation tests should be conducted if new components are added to the freeze-drying process of HPAPIs.
Growth in the anti-counterfeit technologies market will be particularly large in the pharma industry due to increasing awareness around health and safety, says report.
Movilitas has announced that Alter Pharma Group has adopted its Movilitas.Cloud software to meet requirements throughout the product path and changes in packaging under the EU FMD regulation.
After the clinical trial for AZD1222 was halted last week, the studies for AstraZeneca's COVID-19 vaccine candidate will now resume.
Dexamethasone Taw will be examined by the EMA on an accelerated assessment timetable, to assess whether it should be given to patients with COVID-19.
The EMA's PRAC has recommended the revocation of the marketing authorisation for ulipristal acetate, after a review confirmed liver injury caused by the medicine.
According to new research, the global sterility indicator market is set to grow at a CAGR of 10.8 percent over the forecast period.
Liz Thorn outlines the benefits that in vitro diagnostics can bring to the world in light of the current COVID-19 pandemic.
AUC was used to probe the effect of insulin concentration and the zinc chelating agent EDTA on monomer, dimer, and hexamer formation of USP Human Insulin Standard.
NSF expert Dave Waddington discusses the challenges and benefits associated with remote and virtual GMP audits.
Andrew Dunbar outlines five digital technologies that can help pharma function to the best of its abilities over the course of the COVID-19 pandemic.
Blockchain is perhaps best known as the technology on which Bitcoin and other cryptocurrencies are built. Notwithstanding that adoption in the life sciences and healthcare sectors is still in its relative infancy, companies and other organisations in these sectors are increasingly exploring and deploying blockchain solutions. Here, legal experts James…
Laura Trotta explains why risk-based quality management is the best strategy to ensure data integrity of information from investigator-led clinical trials.
Product recalls due to contamination issues can be extremely costly for companies, in addition to the associated health implications. In this article, Marc Baiget Francesch explores the potential risks associated with N-nitrosodimethylamine (NDMA) contamination, why is it such a frequent contaminant and how to detect and eliminate the risks.
There are numerous risks and regulatory requirements that must be considered to ensure appropriate contamination control of sterile medicinal products. Tim Sandle discusses the complexities of sterility assurance and provides guidance for manufacturers to ensure that appropriate risk management processes are in place.