GMP News - Inspections/Audits

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.

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.

Four more EU Member States were evaluated and accepted by FDA and will now benefit from the EU-US Mutual Recognition Agreement for inspections.

Manufacturing and Importation Authorisation holders must not change the terms of the authorisation without prior approval of the authority. But also other GMP related changes require notification to the national competent authority.

Over the past months, the ECA reported about the growing number of Warning Letters issued to Asian companies. A recent FDA Warning Letter resulted in a ban on imports for a Chinese manufacturer of pharmaceutical products.