Producers' Post-marketing Obligations
This chapter suggests that the essential purpose of producers' post-marketing obligations system is to enable the producer to be informed of the risks that appear from use of the products, to evaluate them, and to take appropriate action in relation to the safety of products. Indeed, these are all aspects included in the Quality Systems Standard, ISO 9000, although the scope of legal provisions addressing safety and of quality system provisions are not fully the same: a quality system would certainly be expected to include document retention policies, arrangements for the checking of the quality of ingredients and components as well as the finished product, process control records, and systems for monitoring quality generally and the auditing of the system as a whole from time to time. However, an essential feature is constant reappraisal: the constant evaluation of existing data and conclusions on safety and risk in the light of new data or perspectives.
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