13/14 December 2023
Supplier Qualification and the respective contracts in outsourcing activities are always hot topics in inspections. The inspectorates' summaries of their observations show that things do not always work as desired. Recently, the U.K. authority MHRA (Medicines and Healthcare Products Regulatory Agency) published some very interesting and comprehensive information in their MHRA GMP Inspection Deficiency Data Trend 2015, covering 303 GMP inspections performed in 2015.
The report lists examples for all relevant chapters and annexes of the EU-GMP Guidelines, allowing stakeholders to "perform their own assessment against the deficiency findings as part of self-inspection and continuous improvement".
When it comes to Chapter 7 for example (Outsourced Activities), one can see that problems arise in the whole area of supplier qualification like auditing, adequate contracts and assessing suppliers:
But also Chapter 5 of the EU GMP Guidelines (Production) gives some guidance on auditing and supplier qualification. And the inspectors were not always happy with what they saw: