Aseptic/Sterile Processing

Understanding Containment

March 02, 2017

The new ISPE Containment Manual is a summary of the process involved in the manufacture of highly active or highly hazardous pharmaceutical substances.

Insourcing vs Outsourcing: Choosing the Right Strategy

March 01, 2017

Pharmaceutical Technology Europe

The article reviews strategies for firms with or without existing in-house capacities and the pros and cons for outsourcing bio/pharmaceutical development and manufacturing.

Hospira Receives FDA Warning Letter for Repeated Violations

February 28, 2017

The agency cited the company’s Kansas facility with CGMP violations similar to problems found at other Hospira facilities.

Avella Specialty Pharmacy Recalls Sterile Products

February 27, 2017

Avella issued a nationwide recall of sterile products produced at the Advanced Pharma Houston location due to inaccurate labeling.

Endo Pharmaceuticals Recalls Alprostadil

February 27, 2017

The company is voluntarily recalling one lot of Edex due to a lack of container closure integrity.

Sterile Manufacturing Deviations Found at Japan Facility

February 16, 2017

FDA sent a warning letter to Sato Pharmaceutical Co., Ltd. after inspectors found deviations in the facility’s aseptic processes.

FDA Warns India API Manufacturer Over Contamination Issues

February 15, 2017

PTSM: Pharmaceutical Technology Sourcing and Management

The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.