The last couple of months have seen some catastrophic weather conditions across the globe. These can have a significant impact upon the pharmaceutical supply chain.
We have already received reports of some manufacturing sites being affected and possible shortages occurring as a result. Therefore, we request those companies that have sites within their supply chain that could be at risk due to recent weather events (such as those in Puerto Rico, Southern USA, India and Bangladesh) take steps to identify any potential supply issues.
We are also liaising with our international regulatory partners in order to gain additional information on potential supply issues and support plans to ensure continued supply of products to patients.
You can play a big part by providing relevant information to help with this process.
There is an obligation for licence holders to notify the MHRA of any interruption in supply, for GMP matters this can be done via the Interim Compliance report which should be submitted to firstname.lastname@example.org
Assurances that there are no issues would also be welcomed via the same email address.
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Access our guidance on good practice for information on the inspection process and staying compliant.
Comment by Evan posted on
Clarity on the expectation for GDP in a future post please.
Comment by Mark Birse posted on
Products coming to the UK from the areas discussed will be under the GMP umbrella as they are yet to have been imported and QP certified and entered in to the GDP arena.
That said though we have over the past few years had a number of serious flooding incidents in the UK.
If a UK site is affected by serious weather issues we would again ask that they notify MHRA through the appropriate route - which for GDP is GDPinspectorate@mhra.gov.uk