Entering into the 21st century, the regulatory agencies and the pharmaceutical
industry developed effective risk management programs to minimize the risk of
mycoplasmal contamination in manufactured biopharmaceuticals. The proceedings
contain important presentations which will provide readers with recent information
offered by subject matter experts who presented at the 2005 PDA Workshop on
the contamination of plant peptones.
Appropriate quality risk management programs have been instituted by:
- Identifying the problem
- Avoiding high risk biologically-based raw materials
- Developing a close working relationship between the
vendor of the biologically-based raw materials and the purchasing manufacturer,
- Additional treatment and/or testing of these raw
materials as needed upon QC receipt.