The synthesis of APIs has, in many cases, many stages before the active pharmaceutical substance is obtained.
The Drug Master File defines the part of the process that must consider compliance with GMPs and is associated with the registration of the drugs that incorporate it.
In many cases, this GMP process begins near the end and, therefore, in recent times the Health Authorities require control and audit of the stages leading to the so-called Registered Starting Materials (RSM).
Audits of RSM manufacturers have the difficulty of not having a clear regulatory framework of reference and must be carried out based on risk.
In this Webinar we will share the accumulated experience of having carried out more than 60 audits of RSM manufacturers and that will allow us to provide you with clear criteria to be able to carry out a logical and effective audit approach.
Technical staff from API, and Pharmaceutical industry.
Since 1999, working as a Consultant for Pharmaceutical industry in TDV (www.tdvct.com ), giving services to customers from several European and Asian countries.
Founding partner, Vicepresident and Director of Asociación Fórum Auditorías (AFA) from 2005 (www.forumauditorias.org ). More than 300 worldwide audits personally performed to suppliers and manufacturers of Pharmaceutical, Chemical and Cosmetic industries.