Former MHRA inspector Rachel Carmichael discusses outsourcing areas of your quality system including what would drive this decision, aspects of the operation that can be supported and measures to facilitate the process
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Determination of nitrosamines including gentoxic NDMA analysed by GC-MS in Valsartan using direct injection and headspace methods, below required LOD.
A simple, sensitive and selective direct method using IC coupled to a single quadrupole MS to analyse organic acids in drug solutions.
HPLC with HRAM MS method for the determination and quantitation of nitrosamine impurities in drug products consistent with FDA requirements.
IberoGEN has developed a test to detect COVID-19 for use on surfaces and wastewater in the hopes of aiding in the return to normalcy.
According to findings, the majority of CMOs in Italy are found in the locations hit worst by COVID-19, meaning the pharma supply chain has been greatly impacted.
A group of four CROs at BioCity Nottingham have joined forces to collectively work on the research of COVID-19 therapies.
This webinar will address the evaluation of microbiological, environmental monitoring data as well as what would be considered significant differences in data.
Whitepaper: Establishing the proper alcohol/water proportion for simulating solvents used in controlled extraction studies
This paper provides scientific guidance as well as a case study on the effect of solvent polarity (ethanol/water proportion) on the levels of extractables.
A new report has found that in 2019 the FDA approved 119 new drugs and biologics, but that this is down from 137 in 2018, impacting contract manufacturing organisations.
Whitepaper: Establishing the proper PH range for aqueous simulating solvents used in extractables profiling
This whitepaper considers the chemical properties of commonly encountered acidic and basic extractables and uses these properties to address questions about establishing the proper pH (or proper pH range).
A PricewaterhouseCoopers report has highlighted the directions that the growth of the contract development and manufacturing organisation (CDMO) outsourcing market will take in the near future.
The CDMO AMRI has said it will boost its production of the malaria drug hydroxychloroquine sulfate, identified as a potential COVID-19 treatment, following an emergency use authorisation from the FDA.
An outsourcing company has announced that Phase II, III and IV clinical trials of vaccines will continue at a growing number of sites, assessing the safety of each in light of COVID-19.
Following the initiation of a clinical trial, a COVID-19 vaccine candidate developed by UK researchers is being manufactured in several outsourced facilities.