A3P Scientific & Technical Guide

FLIGHT. N ° 1 - April 2017

EU-GMP Part.1 Chap. 3 and 5

Control of supplier risks and cross contamination.
Studies and condensed regulatory changes.

The demystification of the application of the new 3 and 5 chapters of the European GMPs and related guidelines * is now available in the A3P Scientific & Technical guide:
Control of supplier risks and cross contamination. Studies and condensed regulatory developments EU-GMP Part.1 Chap. 3 & 5.

This guide is the result of collaborative work between manufacturers, suppliers and health authorities.

It allows to understand easily and quickly the new requirements thanks to a detailed analysis of the different texts.

Description of methodologies for calculating acceptability criteria for validation of cleaning processes applicable depending on the products manufactured and the stages of manufacture.
Feedback from the health authorities. Through the various exchanges with the European health authorities, the guide describes the authorities' approaches to questions, interpretations or proposals for implementation.
Provision of a risk analysis tool for the control of cross contamination.

 

*EU Guideline 2015 / C95 / 02 - EMA / CHMP / CVMP / SWP / 169430 / 2012 Guideline on the setting of a standard for the use of dietary agents in different countries. medicinal products in shared facilities