...team of GMP inspectors review automated BCR risk scores and wider intelligence such as compliance history, and SABRE reports to identify triggers for inspection. A key aim of the MHRA’s...
...2008. (The scheme currently has 14 accredited units - 10 commercial and 4 non-commercial. Information on the scheme and the accredited units can be found on the MHRA website). However,...
...the new inspection strategy in GDP, which now features licence inspections covering all sites on a licence as opposed to previous our previous inspection strategy which was primarily site-specific. With...
...incurred up to that point. A further application will then need to be submitted. Existing Manufacturing Sites Where a site has an existing MHRA manufacturing licence or API registration, the...
...request ID. This often still works at Investigator Site inspections and single site organisations which work in paper themselves day to day. However, for large organisations we have found that...
...seen. The people behind these companies disappear when discovered and every product they supplied is then treated as falsified as no history can be established as to the original source...
...of origin or its marketing authorisation holder; or (c) its history, including the records and documents relating to the distribution channels used. Checking your systems comply As part of the...
...from Italy and Greece, where the 2D barcode is not yet implemented. We also provided guidance on what checks should be performed and provided this guidance on our GOV.UK website....
...could replace the need for a contract. A simplified electronic site file specific to the role of the follow-up site reduced the burden of preparing files and archiving. Prior to...
...a Wholesale Dealer’s Licence (WDA(H)) or Broker Registration’: https://www.gov.uk/government/publications/medicines-notes-for-applicants-and-holders-of-a-wholesale-dealer-licence-or-broker-registration Rules and Guidance for Pharmaceutical Distributors 2017, Pharmaceutical Press, London 2017 ISBN 978-0-85711-286-6 (The Green Guide) You may also be interested...
