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 …

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 …

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 …

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, …

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 …

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 …

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 …

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 …