The suggestions for change mainly concern finished medicinal products
(the topics are marketing authorisation, clinical trials,
pharmacovigilance). However, some of the amendments are also relevant to
API manufacturers and can be summarised like this:
- Manufacturers of medicinal products may only use APIs that have been
manufactured according to the GMP principles
- The competent supervisory authority can conduct inspections at the
premises of API manufacturers if there is reason to doubt their GMP
compliance
- The European Pharmacopoeia Commission may ask the EU Commission or
the European authority EMEA to request an inspection if the starting
material is the subject of an API monograph
- In case an inspection at the premises of an API manufacturer leads
to the detection of non-compliance, the information is recorded in a Community
database
Even though this Directive requires API manufacturers to comply with
the GMP principles, the supervisory authorities do not have to conduct
inspections, as in the case of medicinal products. (The English original
says: "The
competent authority may carry out inspections..." and not "...must...")
So there is no legal basis for a national operation ordinance for API
manufacturers either.
On the other hand, there is increasing pressure on the API
manufacturers to follow the GMP principles because the pharmaceutical
companies will have to enforce this requirement against their API
suppliers.
Pharmaceutical API companies will thus be forced to comply with the
principles of Annex 18 to the EU GMP Guide (ICH Q7A "Good
Manufacturing Practice Guide for Active Pharmaceutical Ingredients")
in the manufacture of their APIs if they want to stay in business.
