Inspection Findings in Supplier Qualification and Contracting

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

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:

• There was no proceduralised assessment of the suitability of the Contract Acceptor
• There had been no documented assessment of the suitability of Contract Acceptor
• Technical Agreements and audits were not in place for a number of suppliers
• There was no inventory of Technical Agreements for outsourced activities and no review period
• Assessment of the competence of outsourced service providers was not always completed

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:

• API supplier had been approved without any evidence of audit of the facility
• An audit of the HDPE bottle supplier had been performed; however no response to the audit was available.
• The Technical Agreement did not include sufficient details
• The approved vendor list did not include addresses for all suppliers