Risk based environmental monitoring solution for pharmaceutical microbiology laboratories

Challenge: The FDA believes Manual systems of environmental monitoring (EM) have large inherent operational risks, therefore they are difficult to validate. If it isn't documented, it wasn't done If it wasn't done using an appropriate process, it wasn't done properly 1. Challenge & Solution Solution: Computer trending for pattern recognition is the most efficient and effective way to handle such large quantities of data. Rick Friedman 2 Micro-EM is a newly configured solution developed to handle environmental monitoring of controlled pharmaceutical areas. 1,2 Risk Based Environmental Monitoring (EM) and EM Data Management and Trending An Industry Roundtable Discussion Marsha Stabler Hardiman and Parsa Famili March 11, 2015 PDA NE Chapter Meeting.

1)Risk based environmental monitoring solution for pharmaceutical microbiology laboratories. 2)FDA CFR 21 Part 11 complies, achieving GXP, GAMP5, & FDA requirements and Comply with multiple sets of regulations agencies. 3)Micro-EM manages and automates EM data in a scheduled and workload manner to facilitate EM automation. 4)Simultaneous qualification of process capabilities. 5)Integral handling of deviations and related tasks Micro-EM Features

1)The quality of the laboratory work is only as good as the quality of the samples it uses for testing. Micro-EM automates sampling management schedule and related processes. 2)LIMS is a major tool for operational management of laboratory to ensuring smoother control processes. Micro-EM has a real time process design quality review. 3)Experience your data, any way, anywhere and view a complete picture of your information's in graphical manner. 4)From the sample registration to the final reporting, full laboratory management reporting system. Micro-EM Benefits

Section I: Design Quality by design

Profile Only at the first time, administrator should enter essential set parameters in design, therefore business or company name, Address, logo..etc. should added in Profile screen, next go to Sites tabsheet to add main controlled sites, optionally add report header and footer in Reporting tabsheet. You will need such data in reports.

Layout data is essential for EM, so, in the left table (A) select site and add the associated locations (rooms) then add details of each in the (B) section. Alert and Action Limits must be added., describe associated activities in activities tabsheet, insert location image in diagram tabsheet, define sampling pints on points tabsheet and fill the risk based parameter in Risk assessment table. Finally define the mitigation action taken for minimize the risk severity. Layout

Classification Classification of controlled areas is generally made based upon the level of non-viable particulates in the air. Whatever your reference classification (ISO, USP..etc.) define each grade and associated limits (CFU). Consequently fill in the associated locations (rooms) details in Locations tabsheet. Specific points inside some locations are deferent from the location itself (e.g. LAF), these points should be defined in Points tabsheet.

Section II: Settings Quality by design

Additionally, essential EM settings should determined with the beginning, therefore, try to fill or modify General setting, risk Management settings and Administration settings.

Factors To automate Risk based EM, preset risk factors should be determined. Risk parameters incudes Categories of parameters witch have a direct or indirect presence or absence of risk. Sources and Scores of these influences should be determined. In the Criticality Factors screen sort the numerical factors and define there impact, subsequently, Frequency of each factor must be determined and the associated Locations should be included. To automate Risk based EM, preset risk factors should be determined. Risk parameters incudes Categories of parameters witch have a direct or indirect presence or absence of risk. Sources and Scores of these influences should be determined. In the Criticality Factors screen sort the numerical factors and define there impact, subsequently, Frequency of each factor must be determined and the associated Locations should be included.

Section III: Workload Quality by design

Sanitization Starting environmental control by recording regular and casual sanitization. Record Preparation Date, Preparation batch, Volume and the Disinfectant used (alternatively).

Schedule Consistent follow up of the EM Plan is mentioned in Schedule screen. This screen is updated automatically based on the previous set parameters. Filtration topographies and reporting and exporting services are included.

Monitoring As mentioned in Monitoring Screen find plan date and associated sampling points (A) as scheduled, just double- click over the chosen Plan date to transfer it to Monitoring section (B) complete associated data and save. Repeat double-click over chosen sampling points to fill the section (C).

Investigation Upon the preset action and alert limits, out of Specifications (OOS) and out of trend (OOT) results are collected spontaneously in Investigation screen, i.e. no need for redefine which results is OOS or OOT. Just execute CAPA procedure then record the CAPA Investigation in addition to necessary Actions in CAPA tabsheet.

Tasks Tasks screed includes two types of action first is actions of risk mitigations that recorded in Layout screen and second tasks are the CAPA actions recorded in Investigation screen. You can follow-up the status and responsibility of each action.

Section V: Archive Quality by design

Archive

Dashboard Real time process design quality review (PQR) Classification Quality Layout Quality

Development Team CORPEX Informatics Website: Dear Success partner; This solution is constantly being improved, continuous development and qualification, consequently any observation or advice for improvement is taken into account. Kindly don’t hesitate to contact us for any cooperation. Best Regards