Tips to Qualify Your Pharmaceutical Ingredient Suppliers

Tips to Qualify Your Pharmaceutical Ingredient Suppliers

August 22nd, 2013 // 1:48 pm @

 

Latest FDA and cGMP Compliance News

As most of us know, the globalization of drug manufacturing and the move to the use of many overseas suppliers has greatly increased the complexity and vulnerability of the drug supply chain.

That is why supplier and vendor cGMP compliance at all stages – purchasing, manufacturing and distribution – is getting more attention of FDA investigators. Many manufacturing sites are located far from each other in different climate zones, some of which may have questionable transportation infrastructure.

So, you are going to need to properly qualify your vendors for your drug or device company, but how to do it? Here are some tips we have devised:

  1. Question Phase – What the Vendor Needs to Provide – The first thing to do is to document what you need from this type of vendor. Does the vendor already sell to drug and device companies? Does the vendor have the capacity to supply you with the products? You also really need to understand what your budget is for the services of the vendor. Many weeks can be wasted working on requirements for a vendor, without having set a hard and fast budget number up front. You can possibly use your change control system to document/capture this data.
  2. Understanding Phase – How Vendors Are to Meet the Requirements – After you are done with the question phase, vendors that meet the requirements should be contacted. The requirements are given to the interested vendors. The vendor needs to give you all of its admin information, sales and marketing data and documentation that it has the ability to meet your requirements. You also should request that the vendor give you a sample of the product/service, at least in the case of a device company. You should get this information from at least three vendors before moving on to to the next step.
  3. Evaluation Phase – You need to assess each vendor against your requirements. Keep in mind that all of the potential suppliers at this point have to be able to meet all of your requirements. You should have weeded out the ones that can’t do it. You can set up this evaluation phase in a simple table that has a rating system to evaluate how well each vendor fulfills each requirement. This makes comparison easy.
  4. Site Audit Phase – Now you need to audit the vendor’s facility. You may do this on or off site, depending on how critical the vendor is to you. But it should be restricted to the best vendor that you found during your evaluation, due to cost. You also need to divide your suppliers into critical and non critical ones. By assigning each vendor with this label, you can determine if an on site or off site audit is needed.

For more details on how to qualify your drug and device vendors, please review our upcoming webinar, ‘Qualify Your Vendors – Designing and Implementing a cGMP-Compliant Vendor Program.’


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