WebDec 31, 2024 · RPi applications may be submitted through the MHRA Portal from 1 January 2024. The Responsible Person (import) ( RPi) is described in regulations 45AA and 45AB of the Human Medicines Regulations 2012 ( as amended ). The RPi should be a UK resident. You will need to provide proof of address and identity when you apply. WebJan 29, 2013 · The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health in the UK. The MHRA is responsible for the regulation of medicines and medical devices, equipment used in healthcare, and the investigation of harmful incidents. The MHRA is also the competent authority for blood …
How to manage temporary GDP process changes and risks …
WebFeb 27, 2024 · As announced last week at the MHRA Symposium 2024 the GDP Inspectorate are moving to a licence based inspection model, whereby the overall compliance of all sites named on a WDA(H) will be determined from the inspection outcomes of a selected sample of the sites. ... If you need our help and support then … WebDec 2, 2014 · “The GDP Inspectorate is raising awareness of the impact of the new regulations to those parties that are either directly or indirectly affected and any freight consolidator or freight forwarder either in the air, sea, or road transport sector that is either holding ambient medicinal products on site for more than 36 hours or has cold room ... importance of school organizational climate
Epic Auditors Pharmaceutical Compliance GxP Compliance
WebAs a former MHRA Expert GDP Inspector, Tony has over 32 years experience in various areas of the regulation of pharmaceutical distribution. With 22 years within the MHRA GDP Inspectorate team he undertook the most high profile and complex inspections across the UK. Involved in the development of most UK GDP policies he is ideally placed to help ... WebRichard Andrews, Operations Manager, GMP & GDP Inspectorate, Medicines and Healthcare products Regulatory Agency (MHRA), joined the MHRA in 2001 as a GMP Inspector and is currently one of four Operations Managers within the GMP / GDP Inspectorate. Before joining the Agency Richard worked in the pharmaceutical industry … WebNov 16, 2024 · This is primarily achieved through the GMP/GDP Inspectors Working Group (GMDP IWG). This group of senior GMP Inspectors meets on a regular basis four times … importance of school management system