Bulk product manufacturing contract Contribution from Igor written on 9/3/2010 at 14:49
Is it mandatory to perform an audit of an Contract Acceptor by a Contract Giver in order to asses its competence? Is it acceptable to asses an Contract Acceptor competence by using other tools than audit?
Eudralex vol 4 in part 7 just say that „Contract giver is responsible for assesing the competence of Contract acceptor“, with no reference of how it is to be done.
GMP manual (pub. Maas, Peither, Peither, March 2006.) indicates in chapter 17.A.6. that audit is a requirement from the EU GMP Guideline.
Different Inspectors have a different attitude on this topic. Is it similar to vendor qualification for raw material?
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