Pharmaceutical companies endeavor to manufacture safe and effective products in an increasingly competitive environment. In their anxiety to compete, pharmaceutical companies compromise on safety, resulting in product recall. In 1995, 91 prescription drugs were recalled, this number rose to 401 in 2005, an increase of 200%. Additionally, in 2005, 101 non-prescription drugs were recalled as compared to 61 in 1995, a 66% increase. The primary reason for these recalls was lack of meeting the regulation, specifically the Good Manufacturing Practices. The Food and Drug Administration (FDA) reported that lack of adherence to procedures was the most repeated citation received by pharmaceutical companies. This qualitative phenomenological case study utilized a modified van Kaam method by Moustakas using in-depth, semi-structured interviews to explore the perceptions of a purposive sampling of pharmaceutical managers who have been responsible for achieving and maintaining compliance. The study obtained their perceptions and lived experiences in the challenges that they faced in trying to achieve and maintain compliance. The study also utilized archival data to examine the trends of deficiencies cited by the FDA. Data suggested that the challenges arose from inadequate processes, poorly trained employees, poor drug development, time pressures, and improper documentation. Data also suggested that staff would emulate the pharmaceutical leader about compliance. If the leader is committed to compliance, staff will follow through with compliant practices.
|School:||University of Phoenix|
|School Location:||United States -- Arizona|
|Source:||DAI-B 69/02, Dissertation Abstracts International|
|Subjects:||Pharmaceuticals, Health care|
|Keywords:||Noncompliance, Pharmaceutical industry|
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