Aseptic Manufacturing: A Roadmap to Excellence

Overview:

Aseptic Manufacturing: A Roadmap to Excellence

In recent years, numerous weaknesses within the manufacture of sterile injectable drugs have been identified. As a result, nearly one-third of the industry's sterile injectable manufacturing capacity is off line because of quality issues, according to a Congressional report. The shutdowns have contributed to a shortage of critical drugs, and compounding pharmacies have stepped into the gap to help alleviate the shortages. But several serious health scares have been traced to compounding pharmacies, resulting in much closer scrutiny of the compounding pharmacies' production processes. Manufacturers of sterile injectable drugs simply must do better and be more vigilant to reduce risk and increase product quality with an even greater focus on patient safety.