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February 02, 2022
As Europe moves closer to implementation of ISO IDMP standards, the bio/pharma industry is accelerating efforts to manage its data and documents more effectively.
January 21, 2022
The company is voluntarily recalling one batch of Semglee prefilled pens because of a potential missing label.
January 19, 2022
The company is voluntarily recalling one lot of Senna Syrup 8.8mg/5mL, unit-dose cups because of microbial contamination.
January 05, 2022
Particle analysis provides assurances of the quality and performance of the final dosage form in pharmaceutical development.
Sample preparation tends to be manually labor intensive, but automating this step helps streamline the glycosylation monitoring workflow.
Persistent bottlenecks in biocatalyst development can be alleviated through fully automated enzyme analysis.
January 02, 2022
Continued process verification for a cleaning validation program begins once the validation study is complete.
As regulators balance pandemic tasks and rethink procedures, quality at manufacturing facilities is still a priority.
Siegfried Schmitt, vice president Technical at Parexel, discusses the difficulty of operating non-GMP and GMP quality systems in the same facility.
December 03, 2021
The authors introduce the idea of asymmetrical tolerance intervals as an aid in fully assessing product performance relative to product or process requirements.