Implementing the Falsified Medicines Directive: Safety Features

European Union (EU) member states had until 9th February to implement the final part of the Falsified Medicines Directive (FMD). Member states are required to implement the new falsified medicinal products for the majority of prescription-only medicines, which aims to prevent falsified medicinal products from entering the pharmaceutical supply chain. Read more “Implementing the Falsified Medicines Directive: Safety Features”

MHRA releases final consultation response for the Falsified Medicines Directive

A public consultation was launched by the Government in July 2018 regarding actions that need to be taken to ensure that the United Kingdom (UK) meets its obligations to apply the provisions of the Falsified Medicines Directive (FMD). The FMD requires ‘safety features’ to be applied to the packaging of specified medicinal products. The consultation closed on 23rd September 2018, and the final consultation response has been published with the Medicines and Healthcare Products Regulatory Agency’s response to over 50 replies that were received from a variety of stakeholders. Read more “MHRA releases final consultation response for the Falsified Medicines Directive”

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”