Is it possible to ask the Authorities for a voluntary Inspection of an API Manufacturer?

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

We often receive question where people ask,
a) whether a GMP certificate based on an inspection of an EU Inspectorate can liberate the Marketing Authorisation holder from its responsibility to audit and
b) whether an API manufacturer can ask for an inspection to receive an EU GMP certificate

Already in a Q&A from 2006, it is said that inspection reports or GMP certificates issued by EEA "cannot fulfil the statutory obligations of the manufacturing authorisation holder or the requirements of section 5.25 of the GMP Guide, but the results of inspections, may be used together with other supporting information in a risk-based approach by the manufacturer in establishing priorities for its own audit programme of active substance suppliers".

Now, on the same Q&A website of the EMA, this question is answered again. Here it is clearly stated that "An inspection of the active substance manufacturer by an EEA authority does not liberate a MA holder from this responsibility".

Although there is a provision for the competent authority to carry out inspections of starting material manufacturers at the specific request of the manufacturer, there is "no guarantee that such a request will be fulfilled since competent authorities primarily use risk-based principles to plan starting material inspections". So there is no obligation for the respective inspectorate to do so.