Vendor Management for an API Manufacturer?



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!


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One way of handling is to prioritize the raw material based on its importance. For e.g with respect to API, the raw materials can be prioritized such as

Starting material
Common raw material (Raw material used for more than one products e.g solvents and some of the commercially available raw materials)
Packaging material

Then prepare the supplier questionnaire for the above and it is not necessary that there should be a common questionnaire for all the above three category.

Before going for the audit ensure that the filled questionnaire (by the supplier) is readily available.

Once the evaluation is completed (through questionnaire, sample analysis and audit), you should have the approved raw material supplier list for the material.

With respect to audit of the facility, audit shall be performed for the starting material alone (and it should be described in the SOP).

Hope this may help to start with.


The best place to start with is to have vendor qualification SOP outlining the process of selection.. the raw materials can be critical and non-critical..
Here are some key pointers to consider.. SOP can outline that critical RM vendors be qualified by testing certain number of lots by your or qualified outside lab.. and an audit of critical RMs manufcaturer's mgfing and testing facility to ensure it complies with GMP..
Noncritical RM vendors be qualified by testing certain number of lots by your or qualified outside lab..a paper based audit will suffice (VWR and Sigma may qualify in general if these are your non-ciritical supplier)..
SOP shall also ensure availability of approved list of RM suppliers..SOP shall also outline frequency of audits..
Will not recommend retrospectively qualifying vendor but can be used for non-critical supplier if historical data is available.. hope this helps!


Trusted Information Resource


USP Pharmaceutical Ingredient Supplier Qualification Program

Contract Manufacturing Arrangements for Drugs: Quality Agreements

references are the easy part... NEXT is to aligning your processes... ensuring the the key.
* aligning your processes.....dealing with different scenario, viz., new material (KSM, etc), new vs existing vendors
* use-tests before approving the vendors.
* quality agreements, monitoring the spec - process validations - stability - reprocessed materials etc.,
* finally documentation, periodic reviews/audits, process controls,
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