On 22nd September 2016 the MHRA Inspectorate will be holding another GLP and GCP Laboratories Symposium.
...data integrity in the context of GMP and GDP inspections. Our team has also been working with stakeholders in the international GLP and GCP networks to raise awareness of the...
GDP Guidelines Chapter 3.2.1 “An initial temperature mapping exercise should be carried out on the storage area before use, under representative conditions. Temperature monitoring equipment should be located according to the results of the mapping exercise, ensuring that monitoring devices …
As with most activities in clinical trials, the development of electronic systems is playing an increasing role in methods for data collection. As inspectors we are therefore continually seeing new systems while out and about on inspection, and adapting our …
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