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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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