22 October 2019
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
- What has to be taken into account when preparing an audit at an RSM manufacturer
- Which essential principles of control should be applied during an RSM audit
- How quality risk management processes should be applied for preparation and execution of an RSM audit
You will receive first hand information about this topic from the speakers who are members of APIC‘s 3rd Party Audit Task Force and co-authors of the APIC Guide for auditing registered starting material manufacturers. This is an ideal opportunity to bring your questions concerning RSM audits up for discussion.
This pre-conference session ideally complements the following 22nd APIC/CEFIC European Conference on Active Pharmaceutical Ingredients.
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
- Intention of the Guide
- Some highlights from the Guide
- Advantages to Industry of the Guide
Key aspects and highlights from the APIC Guide
Worked examples from the APIC Guide
Practical examples of auditing RSM suppliers and Hot Topics out of the APIC Guide