ABSTRACT
The term dosimetric release is often applied synonymously with process control release or parametric release. The Parenteral Drug Association (PDA) Task Force and Research Committee suggested that parametric release means the lot release of terminally sterilized product based on measured and documented information related to the operation and control of the sterilization process during routine manufacturing and sterilization of the product. The PDA concluded that the Food and Drug Administration (FDA) Compliance Policy Guide is a qualified statement that does not fully recognize parametric release. Since parametric release will depend on information obtained from measurements and the majority of the data generated critical to the success of the process, a comprehensive calibration program is essential for parametric release. Gaseous sterilization is considered by some practitioners to be inappropriate for parametric release; nevertheless, there seems to be a consensus that the number of variables to be controlled for Ethylene oxide processing does indeed present a challenge.
