Developing a comprehensive cGMP/Quality System for class II biomedical device manufacturing facility
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According to United States Code of Federal Regulations (CFR) listed in 21 CFR Part 820, medical device manufacturers must establish and follow Quality Systems to ensure that their products consistently meet applicable requirements and specifications. If the FDA determines that a manufacturer repeatedly failed to correct the violations FDA outlined in the form 483 and is non-complaint with 21 CFR, a typical first step is issuance of a FDA Warning Letter, which communicates the Agency's position and provides an opportunity for the manufacturer to take prompt corrective action to prevent an FDA enforcement action. Using a qualitative action research methodology, this research was designed to identify and verify the most common causes of FDA warning letters issued to device companies and use these finding to design a standard “implementation plan” that start-up device companies could use to help guide their development of quality systems and prevent issuance of a warning letter. The research consisted of three distinct research phases. The first research phase was to analyze publicly available FDA Warning Letters issued to 120 medical device companies from January 2008 through August 2010 in the area of Good Manufacturing Practices/Quality System Regulations to determine the most common violations that triggered FDA Warning Letters. From the analysis of these Warning Letters, it was determined that violations were most numerous in three broad areas: (1) Design Control, (2) Corrective and Preventive Action and (3) Complaint files. The second research phase was to interview, experts in medical device industry to help attest to the findings in phase 1 and generate qualitative data reflecting expert views for the recurrence of violations in the areas of Design Control, CAPA and Complaint files. Data gathered through interviews were analyzed using the constant comparative method and common themes were identified. The third research phase was to use the analyses of the Warning Letters and the interview data (phases 1 and 2) to design a standard quality system implementation plan that could be used by a small start-up class II medical device company to help assure CFR compliance and avoid Warning Letter issuance.