A3P Scientific & Technical Guide
VOL. 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