NEW: In January 2020, EMA issued a 31 page, draft reflection paper on GMP and Marketing Authorisation Holders (MAHs). The document emphasizes the responsibility of the Contract Giver. What is the QP signing when they release a batch, and what level of raw data do they need to see to support that signature?
“Virtual” company models are now common – no manufacturing, testing or even handling of drug products – all processes are outsourced but the company QP must release the batch.
Importers, and license-holders, even traditional manufacturing companies, in an increasing drive for efficiency, are outsourcing more activities. The planning, coordination and oversight in order to ensure ongoing GMP / GDP compliance is complex. This interactive workshop-style course, will look at process mapping, identifying CCPs (Critical Control Points) and assigning adequate resources to effectively oversee and manage processes.