Qualified Person recalls

When a product defect is identified, the evaluation should include a health hazard assessment by a qualified person, usually a physician. The FDA s recall policy regulations contain a suggested rubric for performing a health hazard assessment (see 21 CFR 7.41). 

A person should be designated responsible for handling the complaints and deciding the measures to be taken together with sufficient supporting staff to assist him. If this person is not the Qualified Person (QP), the latter should be made aware of any complaint, investigation or recall. 

It is interesting to note that the EU does not have an equivalent regulation to 21 CFR 11 but rather claims its basic requirements are already embodied in existing EU GxP directives and standards, such as British Standard (BS) 7799. Indeed, the MCA has stated at conferences that they do not hold to all the requirements prescribed in 21 CFR 11. Harmonization may alter this situation (see Chapter 17). A requirement for corporate computer systems used in the EU that is not specified in 21 CFR 11, however, is the need to define the role of the qualified person in terms of electronic approvals and authorizations. This is especially important for critical GxP actions like batch release, recall, and annual product reviews. Further information on the practical issues affecting 21 CFR 11 can be found in Chapter 16. 

A Qualified Person (QP) has a key position in the pharmaceutical industry and it is that person who releases the batches for the market. The QP deals with quality related complaints and is leading in recall operations. 

Recall Quality Review Quality Improvement Risk Management Process Optimisat ion Personnel Qualified Person Development... 

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