The Maltese competent authority has performed an initial inspection at the facility of an Indian manufacturer and packer in March 2018. This resulted in a Non-Compliance Statement regarding GMP.
Batch certification by a QP is one of the essential requirements in the EU GMPs. However one company in Spain has released products to the market without the QP - with reasonable consequences.
The European Medicines Agency (EMA) has published an updated set of questions and answers on the impact of the MRA between the EU and the US addressing questions with GMP relevance.
A new PIC/S Guidance can help Competent Authorities (CA) prioritising resources for GMP inspections. It also serves as a model for the pharmaceutical industry for their risk based supplier qualification activities.
The EU GMP inspectorates inspected more drug manufacturing facilities in 2017. Also, according to the European Medicines Agency (EMA) states in their Annual Report 2017 there are more inspections performed now in the EU as well.
ICH Q9 is the major guideline providing principles and examples of tools for Quality Risk Management (QRM). But how do competent authorities look at these QRM systems in their GMP inspections?
The use of starting materials in the production process for active pharmaceutical ingredients marks the starting point for GMP. But how can the quality of starting materials be ensured? Find out about what standards for auditing starting materials APIC has defined in their new guideline here.
