Decision tree for the implementation of the Guideline for Good Manufacturing Practices Inspection.

PANDRH WG/GMP. V Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH). Buenos Aires, Argentina. November 17th – 19th, 2008.  Decision tree for the implementation of the Guideline for Good Manufacturing Practices Inspection

The implementation of this Guideline supports compliance with the WHO GMP standards according to Report #32 and updates until 2003, date of preparation of the Guideline.

The Guide for GMP Inspection was adopted by PANDRH at the IV Conference. 

 The working group on GMP (WG/GMP), considering the differences among the levels of development of the pharmaceutical industry in the Region and the political and economic realities of the countries in the Americas, considered it necessary to define a Decision Tree to guide the countries in applying these standards and to set priority of the actions to follow. The document is aimed to guide the NRA and the pharmaceutical industry in prioritizing the requirements of the standards. However, it is estimated that the application of the priorities as they are presented in this document have the flexibility that the national situation requires.

This document is based on a proposal carried out in Venezuela and on resolution 01267 of 2/8/2001 from Colombia.

The document, prepared by the PANDRH WG/GMP members has been approved during their VI meeting (March 2006) as draft for public opinion. It is currently available in the webpage of PANDRH. In compliance of PANDRH process, all comments from the public will be reviewed by the WG/GMP in preparation of the final version.