K
KDail
The company I work for is an API (Active Pharmaceutical Ingredient)manufacturer. I have been given the task of vendor management; an area new to me. I need to understand what the FDA expects regarding Vendor Management specifically for API manufacturers. I am willing to attend training; just not having much luck finding a credible training source online. Would love to get your suggestions. We purchase raw materials from many distributors, and directly from a fair number of manufacturers also. ICH Q7 (GMP Guide for API) is our guiding document, but it is pretty vague on this topic, so I'm trying to find out what best practices are being used. Do I audit Sigma Aldrich and VWR, or do I reach through and audit the chemical manufacturers as well? Our analytical lab (QC lab) performs identity testing on all incoming materials. We have a large number of vendors... where do I draw the line of which suppliers I need to onsite audit and those for whom a questionnaire will suffice?
I'm pulling my hair out, so any help will be appreciated. Thanks!
I'm pulling my hair out, so any help will be appreciated. Thanks!