Environmental Monitoring Performance Qualification (EMPQ) Risk Assessment
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1 Environmental Monitoring Performance Qualification (EMPQ) Risk Assessment
2 Agenda Risk Assessment Environmental Monitoring Performance Qualification Risk Identification Risk Analysis Risk Analysis Exercise Summary 5/8/2018 Company Confidential 2017 Eli Lilly and Company 2
3 RISK ASSESSMENT a systematic process of evaluating the potential risks that may be involved in an activity or undertaking. 5/8/2018 Company Confidential 2017 Eli Lilly and Company 3
4 Risk Assessment Checklist FEMA Fishbone Diagram Flow Chart HACCP Hazard Analysis and Critical Control Points = Systematic preventative approach to microbiological hazard ingress Process Mapping Statistical Tools 5/8/2018 Company Confidential 2017 Eli Lilly and Company 4
5 ENVIRONMENTAL MONITORING PERFORMANCE QUALIFICATION Documented evidence that an area is capable of meeting specified levels for the proposed classification and control measures 5/8/2018 Company Confidential 2017 Eli Lilly and Company 5
6 EMPQ Microbial Control Particulate Control Routine Site Selection Difficult Areas Indirect Indicators 5/8/2018 Company Confidential 2017 Eli Lilly and Company 6
7 RISK IDENTIFICATION Systematic use of information or data to identify hazards 5/8/2018 Company Confidential 2017 Eli Lilly and Company 7
8 Risk Identification Proximity Duration Activity Cleanability Personnel Sterile Components Sterile Equipment Sterile Product 5/8/2018 Company Confidential 2017 Eli Lilly and Company 8
9 Risk Analysis Risk Criteria High (3) Medium (2) Low (1) Numerical Risk Factor Value Qualitative Risk Factor Value Description for Risk Factor Values 1 Low Distant from exposed sterile product, sterile components, and/or sterile product-contact parts 2 Medium Areas adjacent to exposed sterile product, sterile components, and/or sterile product-contact parts 3 High Areas where sterile product/components/equipment are exposed; areas where aseptic connections are made. 5/8/2018 Company Confidential 2017 Eli Lilly and Company 9
10 RISK ANALYSIS An estimation of the risk associated with the identified hazards 5/8/2018 Company Confidential 2017 Eli Lilly and Company 10
11 Risk Analysis Spatial Evaluation Highest Potential Enhanced Detectability Routine Robustness / Reliability Product Impact 5/8/2018 Company Confidential 2017 Eli Lilly and Company 11
12 RISK ANALYSIS EXERCISE 5/8/2018 Company Confidential 2017 Eli Lilly and Company 12
13 Risk Analysis Exercise Up-to-date Drawings Grid Facility Higher to Lower Multi-functional Risk Rankings 5/8/2018 Company Confidential 2017 Eli Lilly and Company 13
14 Proximity to Product (A) Duration of Exposure (B) Frequency of Activity (C) Duration of Activity (D) Cleanability (E) Risk Rankings (A x B x C x D X E) Risk Analysis Report Grid No. Area Classification Room Number Activity Rationale for Risk Rankings 8 A X123 RABS Filling Proximity is ranked high (3) due to sterile filling equipment exposure within the grid. Duration is ranked high (3) due to the sterile filling equipment being exposed throughout the entirety of the filling process. Frequency is ranked high (3) due to aseptic personnel performing set-up activities within the area; additionally, high risk interventions may be required due to operational difficulties within the grid. Duration is ranked high (3) as set-up activities are executed prior to the batch and multiple interventions can be performed throughout the filling process. Cleanability is ranked medium (2) as areas within the grid have smooth surfaces, but some areas not easily accessible for sanitization. 45 B X124 Sterile Equipment Cooling Proximity is ranked medium (2) due to the grid being adjacent to RABS Filler and protected sterile equipment and components stored within the grid. Duration is ranked low (1) due to no exposure of sterile components, equipment, or within the grid. Frequency is ranked high (3) due to aseptic personnel moving and repositioning sterilized equipment / material racks throughout the grid. Duration is ranked medium (2) due to aseptic personnel moving and repositioning sterilized equipment / material racks throughout the shift. Cleanability is ranked high (3) as areas within the grid have some areas that are not easily sanitized, due to equipment / material racks in area. 5/8/2018 Company Confidential 2017 Eli Lilly and Company 14
15 SUMMARY 5/8/2018 Company Confidential 2017 Eli Lilly and Company 15
16 Summary Risk Analysis EMPQ Site Selection EMPQ Execution Routine Site Selection Risk Based Scientific Excellence 5/8/2018 Company Confidential 2017 Eli Lilly and Company 16
17 5/8/2018 Company Confidential 2017 Eli Lilly and Company 17
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