...online BP is updated 3 times a year to include the Ph. Eur. supplements. The BP is brought into effect by the Human Medicines Regulations 2012. The BP contains almost...
...that all staff should be trained in their role, in GDP, in the identification of medicines and in the avoidance of falsified medicines entering the supply chain. There should be...
...should include a list of all Serious Adverse Reactions in section 6 of the APR. Please refer to the MHRA webpage https://www.gov.uk/guidance/clinical-trials-for-medicines-manage-your-authorisation-report-safety-issues#submit-development-safety-update-reports-dsurs Don’t miss the next post, sign up...
...To convey the information please complete and submit an 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...
...law to keep the MHRA informed at all times of the details of the Pharmacovigilance (PV) system. This includes details of the UK Qualified Person for Pharmacovigilance (QPPV) and Pharmacovigilance...
...recorded, handled and stored in such a way that it can be accurately reported, interpreted and verified, while the confidentiality of records of the trial subjects remains protected. If the...
...the drug (medicinal) product across the product lifecycle. EU GDP Guidelines SI 2013/C343/01 First, a little theory Distribution of medicines has inherent risks, and by applying QRM it is possible...
Whilst we progress our latest recruitment campaign for GMDP Inspectors, Ian Holloway reflects on 30 years of working for the Medicines Regulator. My name is Ian Holloway and I am...
...proposed storage area will ensure that the company will understand their storage area and identify any potential areas therein that may be unsuitable to store medicines. A mapping exercise will...
...excipients, packaging materials and medicinal products must be met. Note that the term medicinal product includes in–process, bulk and finished product specifications. Non-compliance with any registered specifications falls outside the...
