...- variations where an inspection is required: 90 working days new applications for registration as Active Substance manufacturers, importers and distributors take 60 working days - if an inspection is...
...checks. As part of your bona fide assessments, we expect you to adopt practices that incorporate independent checks as part of your procedures. When verifying your business partners, it is...
...in IMPs? There is no requirement for APIs used in IMPs to comply with EU GMP Part II in full, but there remains a responsibility for IMP manufacturers to assure...
...GPvP inspectorate. In recent years, GPvP inspections have increased in length and complexity, as result the GPvP inspectorate now performs more frequent inspections of complex systems, where the system is...
...for the Inspectorate here at MHRA. I joined the agency in 2002 after working for 10 years in the pharmaceutical industry. I’m responsible for 4 groups covering our operational activities,...
...been a GMDP inspector since October 2014, and part of my role is to perform inspections of manufacturers, importers and batch certification sites. I trust that you find the following...
...packs are wrapped in paper (hygiene hazard), multiple types of pack are in use, and there is no indication of how long individual packs have been conditioned for. Figure...
...temperature distribution should be investigated. Where non-refrigerated items are introduced to the refrigerator, such as non-conditioned gel packs, the impact of introducing these items should be assessed regarding the increase...
...initiatives. With more than a decade’s experience in science industry skills, it is the expert delivery partner for the Science Industry Partnership (SIP) and works with the SIP to support...
...Interim Compliance Report: https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practice along with the relevant Inspection Report(s). Previous related messages: https://mhrainspectorate.blog.gov.uk/2022/11/08/return-to-international-gmp-inspections/ https://mhrainspectorate.blog.gov.uk/2017/10/19/international-regulators-inspecting-in-the-uk/ [1] https://www.who.int/news/item/05-05-2023-statement-on-the-fifteenth-meeting-of-the-international-health-regulations-(2005)-emergency-committee-regarding-the-coronavirus-disease-(covid-19)-pandemic [2] An explanatory footer has also been introduced in MHRA GMDP database....
