STERILE PRODUCT COMPLIANCE RISK ASSESSMENT FOR ASEPTIC PROCESSING MANUFACTURING
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1 STERILE PRODUCT COMPLIANCE RISK ASSESSMENT FOR ASEPTIC PROCESSING MANUFACTURING Expertise and Training
2 YOUR RISK Aseptic manufacturing processes of sterile products are highly vulnerable against microbial/ particulates contamination If you do not know the inherent contamination risks of your process, the sterility of your product may get compromised Potential risk factors are e.g. poor facility design, wrong company s quality culture, human misbehaviors and errors or lacking process & product controls (list not comprehensive) Finally you have a high risk to deliver contaminated product to the market, and subsequently get heavily scrutinized by regulatory agencies and customers You will certainly loose your good reputation, and certainly run into financial losses. Axys-Network helps and supports you with our experts to mitigate our risks and fix your issues
3 Our service includes the execution of a proactive and independent assessment by outstanding experts in the field. And this should be done BEFORE you run into problems! Our Risk Assessment tool is a well established and functioning HAZOP Risk Assessment method (Hazard Operability Analysis), and has been proven worldwide in the industry successfully since 10 years It is an overall review of your production process and product quality, including Contamination Control Systems, QA & QC Systems, Media Fill Validation, Environmental Monitoring, Personnel Qualification, Training, Operator Behaviors and QA oversight, Aseptic working practices, sterilization methods, quality of utilities such as WFI, (note: list is not comprehensive).. Finally this in deep dive assessment (5 days) results to a simple number and risk- classification, which is called TRF (Total Risk Factor), telling simply the overall risk about your process/ product We will help you to prepare appropriate CAPAs and find resolutions for all of your problems, because we are the experts THE SERVICE
4 Perform a proactive risk assessment BEFORE you run into non-compliance with product quality and audits, find and define appropriate CAPAS Is a beneficial tool for benchmarking between different facilities within your multi-site company The benefit of a 3rd party review by experts will certainly overcome organizational blindness and lower the risks for contamination and audit findings WHY ASSESS
5 The Risk Assessment is a HAZOP (Hazard Operability) method, which is comprised of a comprehensive list of specific questions about each of your production units (currently more than technical questions) Is deep dive assessment into your manufacturing process and controls to review product quality, and will no audit but a teamwork between partners Each technical question will be answered on a scale from 1 (excellent) to 5 (very poor or missing), or with 100 when this topic has an important impact Resulting form all answers the average is multiplied with the inherent risk emphasis factor for each production unit, finally leading to a TRF Total Risk Factor The lower this number and if in the low risk/ green range the process/ product will be acceptable regarding product quality and regulatory compliance Our service includes three tools : Sterile APIs, Finished Dosage Forms Tool is used worldwide since 10 years THE METHODOLOGY
6 FINAL SUMMARY DIAGRAMM
7 Deep dive assessment by independent, world-class experts within 5 days to prevent regulatory and product non-compliance Identifies proactively- the majority of your gaps in your aseptic process Appropriate CAPAs and practical solutions are provided A simple number = TRF and a color represents your overall risk! Is a great and simple tool for everybody, including your senior management, to understand the overall compliance status of their facility CUSTOMER BENEFITS
8 AXYS-NETWORK SERVICES Risk assessment of your manufacturing aseptic lines In-House Training Our experts to deploy the methodology : Dr. Guenther Gapp M. Alain Euzen Contact us: jj.chappaz@axys-network.com
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