Reminders About FDA Requirements for Qualifying Vendors
September 10th, 2013 // 4:13 pm @ jmpickett
From the point of view of FDA, it is not required for a drug company to do a site audit of a supplier or vendor. According to 21 CFR 211.84, all of the lots of all components have to be tested before they can be used for compliance purposes with predetermined specifications.
In a case where the drug company did qualify the supplier, you may be able to cut down on the full testing of all lots of a certain ingredient, if the manufacturer proves the reliability of the analytical testing results of the supplier through a proper means of validation. FDA often notes: Validation of a supplier test results has to be achieved through testing and examinations, not through audits.
To check up on the reliability of your supplier’s results, the drug company should do full tests on the first few lots from the new supplier or of a new ingredient or component, and then compare them to results that noted in the COA for the supplier. In some FDA cGMP inspections, some auditors will write a 483 when the drug company does not do such a comparison at least one time per year. But from the FDA perspective, this is rather too narrow of an interpretation.
FDA cGMP regulations state that once the company validates the supplier, the company can rely on the Certificate of Analysis from the supplier, IF one specific ID test is done on every lot. In this manner, supplier validation is possible to cut down on the need and scope of testing. A drug company also can waive this type of supplier qualification by doing full testing on all lots of ingredients and components received.
FDA generally encourages supplier audits, as an onsite inspection can help to give you more confidence i that supplier. However, doing an audit of the supplier does NOT release you from the responsibility to verify component quality before being used. A validation program that includes audits of the manufacturing of ingredient or component suppliers can also justify longer intervals until the required revalidation.
For more information about dealing with vendor qualification, please refer to our upcoming webinar, Designing and Implementing a cGMP-Compliant Vendor Program.
