Aseptic/Sterile Processing

Feb 28, 2017
By Pharmaceutical Technology Editors
The agency cited the company’s Kansas facility with CGMP violations similar to problems found at other Hospira facilities.
Feb 27, 2017
By Pharmaceutical Technology Editors
The company is voluntarily recalling one lot of Edex due to a lack of container closure integrity.
Feb 27, 2017
By Pharmaceutical Technology Editors
Avella issued a nationwide recall of sterile products produced at the Advanced Pharma Houston location due to inaccurate labeling.
Feb 16, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Sato Pharmaceutical Co., Ltd. after inspectors found deviations in the facility’s aseptic processes.
Feb 15, 2017
By Pharmaceutical Technology Editors
The company has voluntarily recalled all lots of of human chorionic gonadotropin because of a lack of sterility assurance.
Feb 15, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.
Feb 02, 2017
Pharmaceutical Technology
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses how to ensure sterility when manufacturing small-scale parenteral batches.
Jan 25, 2017
By Pharmaceutical Technology Editors
The company issues a voluntary nationwide recall due to the presence of particulate matter in a single vial.
Jan 25, 2017
By Pharmaceutical Technology Editors
The agency finds repeated CGMP violations at Porton Biopharma, Limited.
Jan 09, 2017
By Pharmaceutical Technology Editors
The company was cited by FDA for violations of sterile processing GMPs.
native1_300x100
lorem ipsum