Some additional thoughts:
1. It would be advantageous to use suppliers that can provide a
Cerififcate of Suitability (i.e. confirmation of
compliance with the requirements of the Ph Eur) for API and
excipients - but keep an eye on the EDQMH web site to
make sure that the certificate is not cancelled or withdrawn - since
this avoids some of the difficuties in DMFs
(which are not available for excipients anyway);
2. Make sure that the water for injections used to make the
parenteral product is not produced by reverse osmosis;
3. Make sure the product meets any relevant preservative efficacy
requirements (e.g. for multidose parenteral
products) according to the Ph Eur, and also note that there will be
questions relating to inclusion of benzyl
alcohol as a preservative for some target patient groups);
4. Note that there could be an expectation that the API and
excipients (including water) have suitable bioburden
limits set and that these are checked on a batch to batch basis;
5. Note that there could be an expectation for bioburden monitoring
and controls for the bulk solution - and the
limits will vary depending on whether the product is sterilised by
terminal sterilisation or aspetic
processing/sterile filtration;
6. Note that sterile product made in the US will be subject to site
inspection by EU inspectors;
7. Note that product exported from the US will need to be tested for
compliance with specification on importation
in the EU. The Qualified Person signing the paperwork will need to
include a statement to the effect that the API
is manufactured under EU GMP compliant conditions.
8. Note that the the marketing authorisation holder will need to be
based in the EU or EEA.
..
Regards,
Brian Matthews
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