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...accredited inspector to senior inspector, lead senior inspector, and expert inspector subject to available posts. If you are interested in building on previous management experience, several of our inspectors are...
...expanded principles in ICH E6(R3) and the following table is presented to help you with this. UK Statutory Instrument 2004/1031 (Schedule 1, Part 2) (original legislation) UK Statutory Instrument 2004/1031...
...their details without their knowledge. However the products have arrived in the pharmacy and in some cases payment in advance is requested, with no questions asked and then the items...
...IMP manufacture in third countries which accompany CT applications? All sites involved in manufacturing steps starting with the conversion of the API into the dosage form and including primary and...
...implemented within their quality management system. The processes we have seen during inspections can vary greatly in their detail and robustness, but there are certain elements that are incorporated in...
...MSc in Health Sciences. I had fallen into Pharmacovigilance and spent 6 years in industry working my way up through PV and medical information. I had experience in case management,...
...(MS) and manufacturer specials authorisation (veterinary): https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-manufacturing-sites List of licensed wholesale distribution sites (human and veterinary): https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-wholesale-distribution-sites List of brokers: https://www.gov.uk/government/publications/register-of-brokers-authorised-to-deal-in-human-medicines List of suspended and revoked licences and authorisations: https://www.gov.uk/government/publications/suspended-licences-for-manufacturers-and-wholesalers-of-medicines...
...the inspectorate blog posts about refrigerators posted by MHRA GDP Senior Inspector Steve Todd. What follows applies to pharmaceutical wholesalers; requirements specific to pharmaceutical manufacturers or those involved with laboratories...
...retrospectively and dated with the “date the doctor looked at the results in the EHR”, whilst review of the results in the EHR required the reviewer to confirm this in...
...concerns regarding any transactions or individuals you have dealt/are dealing with, please notify the Inspectorate via gmpinspectorate@mhra.gov.uk and GDP.Inspectorate@mhra.gov.uk, or your last inspector, for further consideration. Further, any concerns or...