The purpose of a supplier qualification is to ensure that supplier’s product is produced under controlled condition, following all applicable guidelines to meet quality conformance. In general the head of Production, Quality Control and Quality Assurance of a drug manufacturer have a shared responsibility to approve and monitor the quality of components provided by suppliers. Quality of these components can partly be ensured by supplier qualification. A brief description of and benefits of supplier qualification is described below.
At the beginning of a supplier qualification process, the regulatory requirements regarding the type of material and specifications are identified. Then supplier audit is planned by indicating the scope of the audit to the supplier. However, according to 21 CFR 211.84 “Testing and approval or rejection of components, drug product containers, and closures” all lots of components used in drug products should be tested fully to assess compliance with predetermined specifications. Therefore 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. FDA generally encourages supplier audits, as an onsite inspection can build confidence in the supplier. Additionally, qualifying a supplier will eventually help manufacturer in cutting down the full testing requirements of drug components. If the manufacturer proves the reliability of the analytical testing results of the supplier through a proper validation then manufacture can release components by doing just one ID test on each lot. Validation of a supplier test results can be achieved through full testing and examinations of first few lots, and comparing the results with supplier’s COA.
Conducting a successful audit of the supplier however does not conclude the qualification process. The compliance of the supplier with the pre specified requirements needs to be evaluated periodically. Furthermore, any changes at the supplier´s site such as manufacturing process; packaging material etc may pose a risk to quality compliance. There should be a process in place so that any change made by the supplier should be notified and agreed upon by the client. A supplier must also notify the client immediately on occurrence of any deviation that may cause negative impact on the material quality. All deviations and non conformities should be assessed collectively to define appropriate corrective and preventive action.
In addition to assessing the quality of the material provided by the supplier, the other important parameters such as quotation time, purchase order execution and delivery time of the material should also be tracked and compared among all the qualified vendors using an established system such as performance scorecard. In summary, the process of a supplier qualification and maintenance is a relationship created to generate a win-win situation for both parties as long as relationship is grounded in strong compliance, transparent communications, and ’right on time’ delivery of the material.
References:
https://www.gmp-compliance.org/gmp-news/what-are-the-gmp-requirements-for-supplier-qualification
http://www.expertbriefings.com/tips/reminders-about-fda-requirements-for-qualifying-vendors/