Process Parametric Release—The Canadian Regulatory View | PDA Journal of Pharmaceutical
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Terminally sterilized products are typically released for market distribution on the basis of a
satisfactory review of the sterilization cycle records and compliance with sterility test results …

The term dosimetric release is often applied synonymously with process control release or
parametric release. The Parenteral Drug Association (PDA) Task Force and Research …

Referring to International Standards on sterilization and sterility assurance of health care
products, prepared by the ISO/TC198, parametric release (PR) or do-simetric release is …

In 2004, FDA published a final guidance for industry introducing the concept of process
analytical technology (PAT) and redefining pharmaceutical manufacturing and quality …

S tcrility of a drug product, in the strictest sense, is defined as" com-plete absence of
microorganisms in the product." However, the test for sterility as described in the …

Pharmaceutical products are generally subjected to end-product batch testing as a means of
quality control. Due to the inherent limitations of conventional batch testing, this is not the …

The intent of this chapter is to review the salient features of process validation relative to the
preparation of sterile dosage forms. The introduction of process validation to the parenteral …

While sterile dosage forms have always been an important class of pharmaceutical
products, the last decade has seen many changes and advancements in the global …

Manufacture by aseptic processing accompanied by end product compendial sterility testing
has been the predominant means of production and disposition of therapeutics requiring the …