news
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
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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.
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European Pharmaceutical Review Issue 4 2019
This issue includes an investigation into the potential for continuous production lines in biopharma, information on new guidance released by China on their regulatory processes and an assessment of the FMD to improve the drug supply chain. Also within the issue are articles on nanomedicine development, monoclonal antibodies and pharmaceutical…
news
17 Spanish infants develop ‘werewolf syndrome’ after drug mislabelling
Young children in Spain have developed hypertrichosis, also known as ‘werewolf syndrome’, after a reflux drug was contaminated with an alopecia treatment.
news
Significant number of drugs on the market not yet fully approved
A large number of drug manufacturers are failing to complete the FDA's Accelerated Approval Program, meaning not all available drugs are fully approved, finds a study.
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Cannabinoids in pharma series: the future prospects of cannabinoids
This series investigates cannabinoids and pharmaceutical interest with industry experts explaining the position of the ingredient. In this third piece, we discuss the future of the cannabinoid industry and how it will grow within the realm of pharmaceuticals.
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Chief executive of NICE to leave role in 2020
Sir Andrew Dillion will be stepping down from his role as chief executive of NICE next year, after holding his position for 20 years.
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On-demand webinar: Designing an End-to-End Sterility Assurance Program
Sterility assurance for a pharmaceutical product is critical, and includes many aspects outside of the actual sterilization cycle or aseptic process.
whitepaper
Whitepaper: Use of accelerated conditions in extractables and/or leachables studies
The purpose of this Position Paper is to consider the scientific basis for accelerating extractables and/or leachables studies via the proper combination of contact temperature and duration (time). Considering this scientific basis, recommendations concerning proper acceleration strategies are provided.
whitepaper
Whitepaper: The use and utility of General Chemistry Data in extractables assessment
The purpose of this Technical Communication is to establish how General Chemistry Data obtained in controlled extraction studies, such as pH, UV absorbance and total organic carbon (TOC), is reported, used and discussed as part of a rigorous extractables assessment.
news
OTC drug manufacturer receives warning letter for data integrity issues
Ningbo Huize Commodity Co has been sent a warning letter for cGMP violations, including data integrity issues.
news
FDA and EMA align on 90 percent of marketing authorisation decisions
A study has found that between 2014 and 2016, the EMA and FDA had very little divergence in their marketing authorisation decisions.
news
US and India receive most warning letters from FDA
New research has found that of the 38 warning letters handed out by the FDA in 2019, the US and India received the vast majority.
news
Emcure Pharmaceuticals receives warning letter from FDA
A warning letter has been sent to Emcure Pharmaceuticals after an FDA facility inspection found that the company did not adequately investigate sterility failures.
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Cannabinoids in pharma series: the challenges of working with cannabinoids
This series investigates cannabinoids and pharmaceutical interest with industry experts explaining the position of the ingredient. In this second piece, we discuss the challenges, legal implications and perceptions of cannabinoids.
