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Dr Lucia Ceresa discusses the importance of accurate microbial IDs for cleanroom performance qualification and the risks of inaccuracies or failures.
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.
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.
The examination of ARB drugs by the FDA will be extended to include other generics with similar manufacturing processes to identify impurities.
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.
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…
Young children in Spain have developed hypertrichosis, also known as ‘werewolf syndrome’, after a reflux drug was contaminated with an alopecia treatment.
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.
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.
Sir Andrew Dillion will be stepping down from his role as chief executive of NICE next year, after holding his position for 20 years.
Sterility assurance for a pharmaceutical product is critical, and includes many aspects outside of the actual sterilization cycle or aseptic process.
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.
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.
Ningbo Huize Commodity Co has been sent a warning letter for cGMP violations, including data integrity issues.
A study has found that between 2014 and 2016, the EMA and FDA had very little divergence in their marketing authorisation decisions.
