Tel.: 06221 / 84 44 0 E-Mail: email@example.com
Alejandro Sureda Salvadó, Farmhispania Group, Spain
Francois Vandeweyer, VDWcGMP Consultancy
This pre-Conference Session provides guidance on how to perform audits at the manufacturing sites of registered starting materials manufacturers. You will get to know
Auditing of registered starting material (RSM) suppliers is a primary activity used by the API Industry in its evaluation of suppliers and materials and is an essential part of the ongoing quality oversight of such suppliers and the materials they deliver. As the manufacture of registered starting materials is not in the scope of ICH Q7 it is unclear against which standards RSM suppliers should be audited. However the expectation from Health Authorities is that the applicant has adequate control on the final API quality. In February 2018 APIC has published a Guide for auditing registered starting material manufacturers complemented by an Aide Mémoire in order to resolve this dilemma. This Guide provides practical assistance on how to perform audits at RSM manufacturers and helps to assure that the authorities’ expectations are met.
This pre-conference session is designed for all persons involved in the manufacture of APIs especially for persons from production, quality control, quality assurance and control, technical and regulatory affairs departments. We are also addressing persons involved in auditing activities and interested parties from the pharmaceutical industry and GMP inspectorates.
The APIC Guide for auditing registered starting material manufacturers – an introduction