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...one organisation at a time, our symposia allow the message to be delivered to a few hundred organisations at a time, but, our blog is enabling us to reach many...
...for monitoring compliance of hospital blood banks. The responsibility for performing these functions has been delegated to MHRA. What this means in practice is that blood establishments are subject to...
...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...
...in order to meet the challenging reporting deadlines set out in the mutual recognition agreement, so that FDA could assess the initial EU authorities in time for the 1st November...
...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...
...thanks and those on behalf of the group to Martin Reed, Senior GLP Inspector at the MHRA, for providing extensive support to the drafting process, and of course to the...
...the use of innovative interventions to ensure the UK continues to provide high quality medicines. We are preparing to pilot a new Compliance Monitor (CM) supervision process for appropriate GMP...
...deemed to be a serious breach 36 deemed not to be a serious breach 1 awaiting further information to enable final determination Patient safety was the main reason for reporting...
...Senior GDP Inspector Tony Orme, and GDP Inspector Terry Madigan, provided delegates with some real examples of the cost of non-compliance to companies. Their key take home message was: failure...
