MHRA GLP Inspection Metrics 2014
...When we have identified an area of overall weakness, this may prompt production of guidance documents or topics for symposia to help to strengthen industry’s knowledge in the areas our...
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Around the world in 80 ways (part 1 of 2)
Posted by:
Ewan Norton, Posted on:
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Categories:
Compliance matters, Good distribution practice, Good manufacturing practice
The supply chain for Active Pharmaceutical Ingredients (APIs) has been increasing in complexity for a number of years with the potential for a number of players to be involved, with...
GCP Serious Breaches - the 2018 Edition
...them prior to dosing any further patients. The sponsor and investigator at a UK site made the clinical decision to go ahead and dose a further subject in the UK,...
It pays to be compliant!
Posted by:
Michelle Yeomans, Posted on:
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Categories:
Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice
...significant amount of new documentation for review in response to inspection deficiencies. Positive benefits for compliance In a bid to drive improved compliance and to cover the cost of managing...
Dose Escalation - is it GCP compliant?
...processes (either by the unit or by sponsor monitoring) especially for data linked to major safety and stopping criteria including pharmacokinetic (PK) or pharmacodynamic (PD) data (for example, a Cmax...
What to expect from GPvP inspections
...produced prior to the inspection, it is rare for exact timings to be set for interview sessions as it is generally more productive and time efficient for inspectors to review...
Guidance around the urgent supply of unlicensed medicines imported out-of-hours by UK hospitals.
Posted by:
grahammatthews, Posted on:
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Categories:
Compliance matters, Good distribution practice, Good manufacturing practice
...to apply for variations to ensure their licences hold the correct permissions. This is especially relevant to hospitals who may specialise in unusual or rare acute conditions. The following is...
Passing the baton from GPvP to GMP: Three top tips for protecting patients and staying compliant
Posted by:
Anna Adams and Trevor Watson, Posted on:
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Categories:
Compliance matters, Good manufacturing practice, Good pharmacovigilance practice
...the new leaflet at the manufacturing site will need to be planned and scheduled to account for the lengthy sea journey and for completion of EU import testing, so that...
Around the world in 80 ways (part 2 of 2)
Posted by:
Ewan Norton, Posted on:
-
Categories:
Compliance matters, Good distribution practice, Good manufacturing practice
...a company is registered and what they are actually registered to do (Manufacturer, Distributor or Importer). For example, if re-packaging, re-labelling or dividing up of active substances occurs then these...
Defective Medicines Report Centre (DMRC): an overview of our work
Posted by:
Sandra Bax, Posted on:
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Categories:
Compliance matters, Inside the Inspectorate, Wider MHRA
...now recruiting for a new DMRC Administrator. If you are interested in an opportunity to join the MHRA, please view the vacancy on the Civil Service Jobs website. Members of...
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