Ireland and Lithuania to benefit from EU-US mutual recognition agreement for GMP inspections

The mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories has made further progress. Lithuania and Ireland have been confirmed by the United States (US) Food and Drug Administration (FDA) as two additional EU Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. Read more “Ireland and Lithuania to benefit from EU-US mutual recognition agreement for GMP inspections”

Pharmaceutical Inspection Co-operation scheme adopts new guidance on GMP inspections

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has adopted new guidance on good manufacturing practice (GMP) inspections. The guidance outlines the process for “desk-top assessment” of overseas facilities to identify cases when an acceptable level of GMP compliance can be confirmed and assured without on-site inspections. Read more “Pharmaceutical Inspection Co-operation scheme adopts new guidance on GMP inspections”

FDA finalises ICH Q7 Q&A document on GMPs for APIs

The United States (US) Food and Drug Administration (FDA) have finalised the International Council for Harmonisation’s (ICH) Q7 question and answer (Q&A) guidance on good manufacturing practices (GMPs) for active pharmaceutical ingredients (APIs). The Q&A document is intended to provide guidance regarding GMP for the manufacturing of APIs under an appropriate system for managing quality. Read more “FDA finalises ICH Q7 Q&A document on GMPs for APIs”

EMA opens consultation on GMP non-compliance statement

The purpose of the consultation from the European Medicines Agency (EMA) is to collect relevant information from stakeholders to help the Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) Inspectors Working Group. The aim is to develop an effective and harmonised risk-based approach for dealing with the supply of critical medicines in the case of serious GMP non-compliance. Read more “EMA opens consultation on GMP non-compliance statement”

MHRA publishes GXP data integrity guide

The Medicines and Healthcare Products Regulatory Agency (MHRA) has published a GXP data integrity guide. GXP encompasses various good practices regulated by the UK MHRA, including the Good Laboratory Practice Monitoring Authority (GLPMA). These are Good Clinical Practice (GCP), Good Distribution Practice (GDP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Good Pharmacovigilance Practice (GPvP). The guidance aims to provide useful information on the core elements of a compliant data governance system across all GXP sectors. Read more “MHRA publishes GXP data integrity guide”

Health Canada releases risk classification guide for drug GMP observations

Health Canada has released a risk classification guide that aims to clarify the manufacturing site inspection process for drug manufacturers. The new guidance for good manufacturing practice (GMP) provides information to ensure a uniform approach that inspectors will use to assign one of three different risk classifications to each noncompliance observation noted during inspections of drug manufacturing facilities. The risk classifications are as follows: critical observation (Risk 1), major observation (Risk 2) or other observation (Risk 3). Read more “Health Canada releases risk classification guide for drug GMP observations”

Four more EU Member States are to benefit from EU-US mutual recognition agreement for GMP inspections

The United States (US) Food and Drug Administration (FDA) has confirmed that it will accept good manufacturing practice (GMP) inspections  performed by Czech Republic, Greece, Hungary and Romania. There are now 12 Member States whose inspection results the FDA can rely on to replace their own inspections, showing that the mutual recognition agreement between the EU and the US to recognise inspections of manufacturing sites for human medicines conducted in their respective territories is progressing as planned. Read more “Four more EU Member States are to benefit from EU-US mutual recognition agreement for GMP inspections”