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.
EU: More Inspections and GMP Non-Compliance Statements
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.
Auditing Starting Materials - new APIC Guideline defines Standards
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.
The GMP/GDP IWG at EMA is currently discussing actions required after an inspection concludes that a manufacturing site does not comply with GMP, and how to make risk based decisions to avoid drug shortages.
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.
Bizarre Warning Letter to Chinese Drug Manufacturer
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.
Chapter 15, which is relevant for medicinal products, has been supplemented by further details on the promotion of collaboration between the individual supervisory agencies and inspectorates. Companies will be better informed now, as well.