Drug Product Problem Reporting Program

Comprehensive records of complaints received either directly from the customer or through a drug problem reporting program should be reviewed. Furthermore, a record of any follow-up investigation of such complaints is mandatory [6] and should be part of this fde. Review of customer complaint records can furnish a useful overview of process performance and possibly hint at product problems. Complaint analysis should therefore be viewed as a meaningful adjunct to the critical process step and control test selection process. 

The Med Check Program will help patients to improve the safety and effectiveness of their drug therapy, including prescription medications, OTC medications, and herbal products. Patients will receive a comprehensive review of all their medications, with a written report and patient education about each of their drug-related problems. A pharmacist will work with the patients and their physicians to develop a plan to address these problems. 

Another component in postmarketing safety surveillance programs is the establishment of enforcement mechanisms to correct product problems. Errors can occur in drug production, packaging, and shipping that lead to adulteration, loss of potency, mislabeling, and other hazardous situations. Prompted by user reports or by results of their own internal quality control procedures, drug manufacturers routinely initiate voluntary product recalls. These actions typically involve limited quantities, or batches, which are cited in public notices of recalls published by the FDA. Product problems that represent serious and widespread threats to public health evoke another form of official publication Public Safety Alerts (entitled Public Safety Reports in Europe). 

Appendix A contains a MedWatch form, which is used by health care professionals for voluntary reporting of adverse reactions and problems widi die drug product. Is also contains advice about vohmtary reporting. This form is a part of die FDA medical products reporting program. 

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