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CEO of Novartis pledges to speed data integrity disclosures
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.
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Federal judge enters consent decree against drug distributors
Two Tennessee companies have been prevented from distributing drugs after a complaint they were supplying unapproved medications.
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EMA to review Picato after rise in skin cancer cases
The EMA will assess the marketing authorisation for the medication to see whether it is a cause of skin cancer in patients.
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Korean pharma company alleged to have conducted trials on employees
Ahngook Pharmaceuticals reportedly held clinical trials on its employees without their consent, leading to the arrest of the company president.
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Pharma reputation worst among other industries in US
An annual report has found that the pharmaceutical sector is the lowest regarded industry among US citizens.
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Developments in stability testing and evaluation
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.
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Allowable levels of excipients in drug products
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.
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ICH Q10 knowledge management
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…
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Sandoz issues voluntary recall for medication bottles
The pharmaceutical company has announced a recall for certain prescription drug bottles which do not meet child-resistant regulations.
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Biofluorescent particle counter-based real-time feedback and control of processing conditions
Biofluorescent particle detectors offer a fundamentally different way of enumerating microbes present in an environment, as compared to traditional growth-based methods. Here, the Process and Environmental Monitoring Methods (PEMM) group shares information about the technology and applications for real-time biofluorescent particle detection methods and how they help to address major…
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Expert View: Annex 1 updates: The impact of microbial ID strategy on cleanroom qualifications for pharma manufacturers
Dr Lucia Ceresa discusses the importance of accurate microbial IDs for cleanroom performance qualification and the risks of inaccuracies or failures.
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Expert View: Data integrity in the QC micro laboratory
The quality control (QC) microbiology laboratory plays an essential role in pharmaceutical manufacturing and product release. Jessica Rayser discusses the importance of data integrity to ensure safe and effective products are manufactured.
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Guide to Single-Use
In this Guide to Single-Use, four pharmaceutical manufacturers present their services and demonstrate their unique offerings as well as an exploration of the future of single-use.
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FDA announces expansion of generic impurity investigation
The examination of ARB drugs by the FDA will be extended to include other generics with similar manufacturing processes to identify impurities.
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QA/QC & Analytical Techniques In-Depth Focus 2019 featuring Environmental Monitoring
This In-Depth Focus highlights why bio-fluorescent particle detection is an effective method for enumerating present microbes and discusses ICH Q10 knowledge management; presenting five tips for improving your company’s knowledge management.
