...weakens the effectiveness of other governance measures. The same principle applies to the supply chain. A failure at one site weakens all sites downstream in the chain. To keep the...
...use (CHMP) as part of a marketing authorisation application, this can be problematic. If the inspected sponsor site is outside of the European Union (EU), the ability to add additional...
...the PIC/S audit system called the Joint Reassessment Programme (JRP). Details about the on site assessment of MHRA are the subject of an previous post to this blog. JAP belongs...
...Single Inspection Program (SIP). This pilot aims to establish a coordinated global approach to GMP inspections of foreign manufacturing sites of common interest. Using our collective inspection resources, each authority...
...The paper also covers areas where we felt remote or distant assessment approaches were suitable versus those technical areas where on-site was required to ensure the appropriate safety and quality...
...away from hospitals and GP sites due to existing health problems that may put them at risk of infection, or they may be reluctant to travel to sites where there...
...sites/on other trials? how do you know this is an issue only at one particular site if you have not checked across sites? what root cause assessments have been undertaken,...
...report. When stock is lost at a third-party storage site or while in transit with a courier this may be more likely to be reported internally by the company owning...
