Regulatory Compliance in Aseptic Manufacturing Outlined in New Brief

Have you ever wondered about the level of oversight of aseptic manufacturing of medical products and devices?  Microtest Laboratories, Inc. is offering a new management brief that explains how a best-practice control and monitoring system can minimize the danger of FDA noncompliance in aseptic manufacturing facilities. The brief is available for download at:

In the aseptic manufacturing business, all processes must be best practice to ensure the process will comply with the regulations. If any are poorly designed, not utilized, or deviated from, then the entire aseptic manufacturing system is considered out of compliance. This means that the checks and balances of a quality system must ensure that the sterile environments and surrounding support standard operating procedures (SOPs) truly are working and show no signs of trending toward failure.

The new management brief, "Weathering the Storm of Regulatory Compliance in Aseptic Manufacturing," outlines six critical areas that should be addressed to avoid the possibility of product contamination:
- Training and professional development
- Environmental monitoring (EM) procedures
- Incorporation of single-use technology (e.g., needle/tubing sets)
- Facility design and maintenance
- Process simulation
- Raw material control, preparation and sterilization

"The FDA has been very critical of aseptic fill/finish companies whose manufacturing environments are out of trend or outside of specifications," noted management brief author Alexander Mello, MS, SM (NRCM), director of project management for manufacturing at Microtest Laboratories, Inc.  "Rigorous production system control and monitoring through data generation and analysis will pave the way for best-practice pharmaceutical manufacturing," he adds.