PICS Guidance on Parametric Release

Parametric Release (Real Time Release Testing)

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.

PURPOSE

 

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.

SCOPE

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. 

PART I

Elimination of routine sterility testing for parametric release

PART II

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

APPENDIX II

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

Read also:

• Different Types of Stability Studies in Pharmaceutical Industry
  
• Quality Compliance in QC Laboratories

Resource Person: BARBARA PIROLA