Active Pharmaceuticals Ingredients (API’s) must always comply with authorized
specifications requirements for release and retest dates. Assurance with which these
products can be accepted for release depends on many aspects of the manufacturing
process and supply chain, and the sampling and testing may be reduced without
compromising the quality of the API.
It is recognized that a manufacturer may obtain sufficient assurance that a product
meets all stipulated quality specifications through “A system of release that gives the
assurance that a product is of the intended quality based on the review of information
collected during the manufacturing process and on the compliance with specific GMP
requirements related to parametric release.” (ref. 3)
A comprehensive set of process measurements and controls will provide greater
quality consistency of the product meeting the specifications than traditional QC
testing. A toolbox would be or could be utilised containing more tools than before (on-
line, in-line, at-line and off-line measurements).
Parametric release is such a system, which is based on evidence of successful
process validation of the API manufacturing process in qualified and correctly
maintained production equipment and facilities, and review of the documentation on
process monitoring and in-process data performed to provide the desired assurance
of the specified quality of the product. Parametric release is therefore an operational
alternative to routine release testing of samples taken from every finished batch to be
tested according to release specifications.
Implementation is in line with the text in the Ph. Eur.(ref.1).
This document is intended to give guidance for applications that propose parametric
release for Active Pharmaceutical Ingredients and isolated intermediates that are
intended for commercial use.
The guideline highlights the different requirements that have to be fulfilled in the
The principle of parametric r