Due to the restrictions caused by COVID-19, the period of validity GMP and GDP certificates issued by MHRA is automatically extended until the end of 2024, except where clarifying remarks in...

2014年12月18日 · The Medicines and Healthcare products Regulatory Agency (MHRA) carries out inspections to check if manufacturing and distribution sites comply with GMP or GDP. You will be inspected...

A certificate of Good Manufacturing Practice (GMP) is issued to a manufacturer if the outcome of the inspection confirms that the manufacturer complies...

2023年12月11日 · GMP and GCP Inspectors work closely with MHRA Clinical Trials and regularly provide support to help answer a wide range of stakeholder queries which relate to the manufacture, import,...

2024年2月20日 · This pilot aims to establish a coordinated global approach to GMP inspections of foreign manufacturing sites of common interest. Using our collective inspection resources, each authority has...

2024年11月24日 · In the UK, GMP compliance is mandatory for manufacturers and is regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). This article delves into the fundamentals, requirements, and implications of GMP in the UK pharmaceutical landscape.

2023年12月11日 · The validity of GMP and GDP certificates has currently been extended until the end of 2023. The MHRA (in consultation with our international partners) has decided to continue the extension of...

MHRA-GMDP contains information relating to manufacturing and wholesale distribution authorisations, API registrations and GMP/GDP certificates.

2015年5月29日 · 本文提供了MHRA对制药行业GMP数据完整性方面的指导原则。本指导原则旨在对现有欧盟有关原料药和药物制剂的GMP进行补充说明，需结合国家药品法规及颁布在Eudralex 第四册内的GMP标准进行阅读理解。

2021年3月17日 · National documents from the UK authority such as GMP certificates and inspection reports for locations in the UK will continue to be accepted in the EU as confirmation of GMP compliance in connection with regulatory submission and/or import applications.