The European Commission published a draft revision of Annex 1, on Manufacturing of Sterile Medicinal Products (1). One purpose of the revision was to introduce principles of Quality Risk Management (QRM) to allow the adoption of new technologies and innovative processes. The upcoming Annex 1 revision will include guidance specifically on designing a risk-based and effective contamination control strategy (CCS) based on a scientific assessment to understand the process and to apply risk management principles.
In line with the CCS, the selection of EM sampling sites as well as methods is crucial for the GMP manufacturing environment. Sampling locations & methods of sampling should not by itself generate cross contamination. The EM data should be reviewed routinely and assessed performing trend analysis; data tracking system & software’s are also being implemented respecting data integrity.
During the live event, the experts discussed:
Sabine Bessières Recasens
Western Europe Field Marketing Manager, BioMonitoring
Sabine Bessières Recasens leads the Environment Monitoring products for Pharma cleanrooms and isolators in the Field Marketing BioMonitoring Life Science Western Europe at Merck KGaA, Darmstadt, Germany. She works for health industry since more than 25 years in Product and Marketing Management: first in development and sales of solutions for blood components preparation and medical diagnostic, then methods for industrial microbial testing more in Pharma, Biopharma. She is involved in users’ regulatory guidance and microbiology scientific support, trainings and conferences and has been a member of the French committee AFNOR X44B "Cleanrooms for 10 years.
Anne Grit Klees
Global Product Manager Environmental Monitoring
Anne Grit Klees is lead expert and portfolio manager in the environmental monitoring segment of Merck KGaA, Darmstadt, Germany. Anne-Grit received her PhD in Microbiology at Philipps University Marburg in 1992. She has more than 25 years of experience in managing instrumentation and consumables for microbial testing in pharma, food and beverage industries. Her focus is air and surface monitoring in cleanrooms and isolators, with expertise in regulatory, technical and user requirements. She is always involved in innovation projects to improve our customers experience with new and compliant solutions.
Head of Microbiology and Sterile Technology Expertise
Benoît Ramond is Doctor in Pharmacy at the University of Paris XI in France and obtains a PhD in Microbiology. He has more than 30 years of experiences in the Pharmaceutical Industry. Since 2016 he is Head of Microbiology and Sterile Technology Expertise in Sanofi Group including Aseptic Processing, Barrier Technologies, Environmental Monitoring Program, Cleaning and Disinfection, Visual Inspection. In his function he has also a leading role in the Annex 1 implementation program within Sanofi.
Aspen, Normandy, France
Senior Expert on Microbiology, part of the Centre of Excellence for Sterile
Andrea Conti is the senior expert on microbiology working as part of the Centre of Excellence for Sterile at Aspen, Normandy, France. Degree on microbiology at Rome “La Sapienza University”, he as now more than 21 years of experience on pharmaceutical industry. His career started at Sanofi, Italy, as microlab Team Leader, then he had the role of microlab manager. Left Italy, he become sterility assurance manager for 6 years at Sanofi-France and now he is part of Aspen since 2020. He as a long experience on environmental monitoring, trend analysis and sterility assurance and recently he has developed Contamination Control Strategy for some processes at Aspen. Main job now is to give assistance to 3 sterile sites for strategies and troubleshooting on sterile domain.
Delpharm, Saint Rémy sur Avre, France
Expert on Microbiology, Sterility Quality Assurance Department
Audrey Schultz is the expert on microbiology working for Sterility Quality Assurance department at Delpharm, Saint Rémy sur Avre, France. She as now 20 years of experience on pharmaceutical industry, started as microbiological lab manager and QC manager. She become sterility assurance manager since 2017 with the management of environmental monitoring, trend analysis, risk analysis and she is QA project leader. She is working with the Delpharm sterility group to develop the CCS and the new Annex 1 gap assesment.
Head of Field Marketing and Validation Services, BioMonitoring
Louisa Patterson who moderated the discussion is the Head of Field Marketing and Validation Services, BioMonitoring Life Science Western Europe for Merck KGaA, Darmstadt, Germany. Louisa has worked in the Life Science industry for the past 20 years holding several different roles in Global Strategic Accounts, Marketing and Sales. Throughout her career she has worked closely with customers within the Pharmaceutical and Biotech, Diagnostic and Contract Testing Industries to understand and support specific industry related needs as well as defining key strategies to address these markets. She graduated in Molecular and Cellular Biology from the University of Glasgow, Scotland, and earned her Master’s degree in Cellular Biology from the University of Wales, Aberystwyth, partnered with the AO Zentrum, Davos, Switzerland.
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