Supplier Qualification is a hot topic in inspections. The inspectorates' summaries of their observations show that things do not always work as desired. In a presentation published by the end of last year by the U.K. authority MHRA (Medicines and Healthcare Products Regulatory Agency), it is stated that "deficiencies relating to 'Quality Systems' are by far the most prevalent observed during inspections". The report "GMP Inspection Deficiencies 2013" covers 630 inspections performed in 2013. According to the report, deficiencies in supplier and contractor audits are amongst the top 5.
Taking a closer view at the examples of the observations, one can see that problems arise and the whole area of supplier qualification like auditing, audit plan, audit report, adequate contracts and managing unapproved suppliers:
The respective audit report was not available.
There was no evidence upon which to base the approved manufacturer decision
The address of a supplier site differed from the address on the audit report
In the audit reports it was not apparent what had actually been audited
The maintenance and control of the approved supplier list was not robust
API was received although an audit specified that the supplier was no longer approved
Risk based audit planning defines no maximum time frequency
Quality Assurance Agreement was not kept up to date.
Quality Assurance Agreement failed to adequately describe transportation conditions.
Approved supplier list was inadequate, e.g. not all suppliers were listed and some suppliers were listed that should not have been.
Supplier audit SOP did not cover API suppliers and other services.
After concluding that an API supplier was not suitable for the supply, the API already received and held on stock was not quarantined and rejected.