PICS Guidance on Parametric Release

 

A system of release that gives the assurance that the product is of the intended quality based on information collected during the manufacturing process and on the compliance with specific GMP requirements related to Parametric Release.

 

 

 

The purpose of the document is to provide guidance for GMP inspectors to use for training purposes and in preparation for inspections of company premises where Parametric Release has been approved or applied for. 

 

In addition the document provides a framework for GMP inspectors and Marketing Authorisation assessors to work together and jointly approve an application for Parametric Release.

 

 

 

This guidance attempts to cover a wide scope that includes a reduction or elimination of routine finished produc ttesting. Within the Finished Product testing group the elimination of routine sterility testing is a primary focus of interest. 

 

 

Elimination of routine sterility testing for parametric release

 

Reduction or elimination of other finished product testing for parametric release

 

APPENDIX I

RECOMMENDATIONS FOR A GENERAL STERILITY ASSURANCE SYSTEM FOR TERMINALLY STERILISED PRODUCTS AND PROVISIONS FOR PARAMETRIC RELEASE

 

DETAILED GUIDANCE CONCERNING THE REDUCTION OR ELIMINATION OF OTHER FINISHED PRODUCT TESTING