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December 28, 2017
The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.
December 20, 2017
FDA sent a warning letter to Deserving Health International Corp. after inspectors found CGMP violations including failure to prevent microbiological contamination.
December 06, 2017
The contract research, development, and manufacturing organization has expanded API aseptic manufacturing capacity at its Valladolid, Spain, facility.
November 15, 2017
Alternatives to time-consuming, error-prone operations promise to reduce vaccine manufacturing costs and improve facility flexibility.
November 02, 2017
The revised Akers-Agalloco aseptic risk assessment and mitigation method includes two sub-methods that can be used independently for risk assessment.
October 23, 2017
The company is recalling several injectable products because of possible microbial contamination.
EDQM held a symposium on microbiology to gather industry feedback on alternative testing methods for microbiological control and sterilization processes.
October 18, 2017
Water shortages, testing expenses, and effluent treatment are important issues for pharma manufacturers.
October 11, 2017
Xellia Pharmaceuticals invests US$25 million in its Copenhagen, Denmark site to expand sterile manufacturing of products for treating antimicrobial resistant infections.
October 05, 2017
Groninger will showcase its FlexPro 50 line for small batch production at CPhI Worldwide 2017, and present on up- and downstream processes with freeze-dryer developer and manufacturer Martin Christ.