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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