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LIMS requires a high degree of customization to meet QC Microbiology requirements. This means LIMS implementations often lock users into a functionality set that can’t accommodate technology advancements and regulatory changes without considerable investments, time, effort and money.
The EMA has announced it is drafting guidance on how to avoid the presence of nitrosamines, a probable carcinogenic ingredient, in drugs.
CPhI Worldwide will return for its 30th year on 5-7 November 2019 at Messe Frankfurt in Frankfurt, Germany.
The EMA and the FDA are investigating some ranitidine medicines after they were found to contain NDMA, a probable human carcinogen.
The FDA says that even though it recognises the importance of compounded drugs, they also pose a risk to patient safety.
Bacteriostatic Water is being recalled because of a lack of sterilisation confirmation for some vials.
Research has found that the worldwide LC-MS market will be worth $2750 million by the end of the forecast period in 2024.
Novartis reportedly knew of discrepancies in the Zolgensma data it had submitted to the FDA but delayed informing regulators so has announced alterations to its processes.
Two Tennessee companies have been prevented from distributing drugs after a complaint they were supplying unapproved medications.
The EMA will assess the marketing authorisation for the medication to see whether it is a cause of skin cancer in patients.
Ahngook Pharmaceuticals reportedly held clinical trials on its employees without their consent, leading to the arrest of the company president.
An annual report has found that the pharmaceutical sector is the lowest regarded industry among US citizens.
The Joint Pharmaceutical Analysis Group (JPAG) held a stability meeting at the Royal Society of Chemistry’s headquarters in London earlier this year. Attended by 65 delegates, its focus was on developments in stability testing and evaluation. Here follows a summary of the presentations made at the meeting.
Medicinal products typically cannot be manufactured without using excipients. Here, Dave Elder and Fabio Faïs discuss factors for excipient selection and the importance of defined allowable limits to ensure continued product safety.
The efficient handling of information and resources is key for achieving success within a commercial organisation. Against the backdrop of ICH Q10 – the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use – Christian Rack discusses five things you can implement right now to…
