PACT July 20, 2006 Web Seminar Presentation

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PACT July 20, 2006 Web Seminar Presentation

Deviation Management SystemTools• Standardized Form• User Friendly Database - Microsoft® Access• Graphs & Tables - Microsoft® Access/Excel• Reports


Why a deviation database?• Flexible and powerful means oftracking deviations• Identifying recurring and sentinelevents• Facilitates regulatory compliance• Promotes continuous processimprovementDeviation Database Design• Easy to use• Categorization of deviations• Product/patient impact scoring• Analysis and graphic display• Report capabilities• Pick-lists, description codes, clients, tech,equipment etc..


Additional Features• Security-compliant with FDA regulations(21CFR11)– Requires usernames/passwords– Access limited to dedicated staff– Secured from unauthorized users• Reviewed by Operations Manager• Audit trails– Username, original & added data, date/time of entry– Complete tracking of data from initiation to modificationto deletion• Daily virus scanning• Backed-up on server; in fire-proof safe; off-site“Nuts and Bolts” of a DeviationManagement System• Functions of the quality program must include:– Investigating and documenting HCT/P deviations and trends ofHCT/P deviations relating to core cGTP requirements...[Sec. 1271.160(b)(6)]• Periodic review and analysis of all deviations, at least once a year(proposed GTPs)• Reporting:– You must report to FDA an adverse reaction involving acommunicable disease if… [Sec. 1271.350(a)]– You must report HCT/P deviations (relating to the core cGTPrequirements) related to a distributed HCT/P for which youperformed a manufacturing step if deviation occurred in yourfacility or another facility under contract, agreement or arrangement[Sec. 1271.350(b)]


Document & Investigate• Complete deviation form• Investigate in real time• Determine if need for…– Corrective Action/Preventative Action(CAPA)– Root Cause Analysis/Investigation– Investigational ReportReasons for Root Cause InvestigationExamples• Moderate – Severe Risk to Patient Outcome– CD34 Selection Failure– Cord Blood Product Mix-up– Adverse Reactions– Engraftment Failure• QA System Failures– Equipment Monitoring Failure• Impact upon Multiple Products/Patients– Defective Freezing Bag


Investigational Report• Description– Description of event– Data, test results, documents– Identification of members of the review committee– Patient impact, outcome analysis• Review Committee– Identify root cause– Determine if reportable and to whom– Identify corrective plan• Corrective Plan– Define with timeline– Implement– Monitor“Nuts and Bolts” of a DeviationManagement System• Functions of the quality program must include:– Investigating and documenting HCT/P deviations and trends ofHCT/P deviations relating to core cGTP requirements...[Sec. 1271.160(b)(6)]• Periodic review and analysis of all deviations, at least once a year(proposed GTPs)• Reporting:– You must report to FDA an adverse reaction involving acommunicable disease if… [Sec. 1271.350(a)]– You must report HCT/P deviations (relating to the core cGTPrequirements) related to a distributed HCT/P for which youperformed a manufacturing step if deviation occurred in yourfacility or another facility under contract, agreement or arrangement[Sec. 1271.350(b)]


Review & Analysis• Quarterly basis• Collectively and for each client• Formally track/trend by product type,category, patient/product impact,equipment, etc..• Present and discuss with each client


“Nuts and Bolts” of a DeviationManagement System• Functions of the quality program must include:– Investigating and documenting HCT/P deviations and trends ofHCT/P deviations relating to core cGTP requirements...[Sec. 1271.160(b)(6)]• Periodic review and analysis of all deviations, at least once a year(proposed GTPs)• Reporting:– You must report to FDA an adverse reaction involving acommunicable disease if… [Sec. 1271.350(a)]– You must report HCT/P deviations (relating to the core cGTPrequirements) related to a distributed HCT/P for which youperformed a manufacturing step if deviation occurred in yourfacility or another facility under contract, agreement or arrangement[Sec. 1271.350(b)]


ReportingSec 1271.350• Focused on…– Product Contamination– Transmission of communicable disease– Failure of product function or integrityFinal Thoughts…• Keep system practical, efficient, anddynamic• Realize that deviations will occur– Complexity of field & human nature• Primary goal is quality improvement


Acknowledgements– Diane Kadidlo– Darin Sumstad– Jeff McCulloughMcKenna D, Kadidlo D, Sumstad D, McCullough J. Development and operation of aquality assurance system for deviations from standard operating procedures in a clinicalcell therapy laboratory. Cytotherapy 2003; 5(4):314-22.

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