
Modus
GMP/GDP Symposium

The MHRA Inspectorate have recently published blog posts on the GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) Symposiums that took place in November 2018.
A brief summary of events for GMP:
An update on 'Brexit' was given.
Deficiency data was presented looking at 2017 inspections. Main deficiencies were Product Quality Reviews (PQR) and Data Integrity.
The FMD was also discussed with a recap of requirements given.
Videos were on loop during the lunch break and covered topics on Advanced Therapy Medicinal Product (ATMP) manufacture; Patient Specific Medicines; Elemental Impurities; and GMP and Marketing Authorisation Holders (MAHs).
A presentation was given on the application of current GMP to new technology.
An update was given on the public consultation for Annex 1 - Sterile Medicinal Products.
The topic of Importation (licencing, testing and certification requirements) was also discussed.
The full MHRA blog can be found here:
GMP (Good Manufacturing Practice) Symposium
A brief summary of events for GDP:
An update on 'Brexit' was given.
Risk-assessment of change management was discussed.
Top deficiencies for GDP inspections were listed as Quality Management; Transport; Qualification of Customers; Returned Medicinal Products; and Responsible Person.
A presentation on training and training records was given.
An update was given on the requirements of Active Pharmaceutical Ingredients (APIs).
The FMD was also discussed with a recap of requirements given.
The full MHRA blog can be found here:
GDP (Good Distribution Practice) Symposium
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