03/01/2012Suppliers' qualification

With each passing day, new suppliers and manufacturers of packaging materials, raw materials, laboratories, etc., appear, offering products and services of different quality levels. It is, therefore, of paramount importance that the company have a robust Evaluation Program Suppliers in order to maintain then quality of products being manufactured and reduce the sanitary risk.

The qualification program may include suppliers of Raw Materials, Finished Products, Packaging and Labels. The application of this Qualification Program does not ensure, by itself, the qualification of the supplier and the absence of failures. The acceptance of the results of evaluations, accreditations, selections, and possible third-party certification, are under the responsibility of the purchasing companies and contractors. In other words, they can decide negotiations regardless of the results of this process. Certification programs do not exempt companies from committing faults, errors, but show, clearly, their attitude towards their customers, to fix, in a corrective and preventive manner, all non-conformities.

Tool For Risk Management In Supplier Qualification As ICH Q9

The use of the tool "Risk Ranking and Filtering" (RRF) in the pharmaceutical industry began in early 2002, when the FDA noted that, due to the increasing number of laboratories, it lacked the resources necessary to perform the routine inspections that were programmed . So it was essential to establish a methodology for risk analysis to prioritize inspections, i.e., define which laboratories should be audited in the first place, according to the risk of its activities involving public health.

The method of "Risk Ranking" can be defined as a risk analysis tool that enables the comparison and evaluation of the risks. If the "Filtering" is added to this method, a filter will...

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