...the Licence Holder or managing director. When operating under the contract, generalised solutions are unlikely to be appropriate; it is not acceptable for the RP to introduce a generic quality...
...have to be a Responsible Person (RP) to be a GDP inspector you do not have to be a Qualified Person responsible for Pharmacovigilance (QPVP) to be a GPvP inspector...
...satellite sites and that these sites are compliant. This also allows the inspectorate to redirect resources towards sites deemed to present a greater risk according to the established risk-based inspection...
...risk to GMP compliance. Key personnel are therefore expected to have been employed or contracted to the site for a period of time before an application is made to name...
...have been seen where updated systems are available for the investigator to use prior to approval by the MHRA, or that the site has been told to implement at protocol...
...of the wholesale distributor to ensure that vehicles and equipment used to distribute, store or handle medicinal products are suitable for their use and appropriately equipped to prevent exposure of...
...8.3.24. The eCRF is therefore a mechanism for the investigator to enter data into an electronic system to transfer to the sponsor. It is a form of electronic data capture...
...considerations. Therefore, it is up to organisations to determine the best way to approach this as per their quality system, and there is no statutory requirement to have a stand-alone...
...are reviewed periodically. This is necessary not only to check for updates to the RSI, but in general to make sure that changes to the SmPC are acknowledged to protect...
...to these deficiencies, integrity of the data could not be confirmed. The EHR had a functionality to be locked to prevent further edits to the data entered. However, it was...
