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© 2023 MJH Life Sciences and BioPharm International. All rights reserved.
© 2023 MJH Life Sciences™ and BioPharm International. All rights reserved.
October 01, 2022
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, addresses the difference between regulatory compliance and real compliance.
September 15, 2022
Document integrity is critical in the provision of raw materials for cell and gene therapy manufacturing.
September 01, 2022
A process flow diagram can help create an agreed-upon process flow for a third-party standard operating procedure, says Siegfried Schmitt, VP Technical at Parexel.
July 20, 2022
Hospira has issued a voluntary nationwide recall for one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), due to the potential presence of visible particulate.
July 06, 2022
An SOP for electronic-records archiving is a regulatory requirement and good for business, says Siegfried Schmitt, vice president, Technical at Parexel.
July 01, 2022
Agency leaders are moving to develop a rating system to identify those drug manufacturers with more dependable production operations.
June 10, 2022
The agency’s Medicines Shortages Steering Group has adopted a list of critical COVID-19 vaccines and treatments so they may be monitored for potential shortages.
June 08, 2022
One get obtain a clearer assessment of gene-editing outcomes through more exacting analytical tools.
June 02, 2022
Having a clear clinical strategy early on can shave time off overall development projects.
Extensive work has greatly expanded the possibilities for fetal bovine serum sourcing.