Quantify your Non Compliance

A quantitative evaluation by independent experts over a period of 5 days

  • Proactively identify most of your gaps in your aseptic process
  • Appropriate CAPA and practical solutions are provided
  • A simple number = TRF and a color represents your overall risk!
  • It is a simple tool for everyone, including your management, to understand your compliance

Our Risk

  • Aseptic manufacturing processes for sterile products are very sensitive to microbial / particulate contamination
  • If you do not know the risks of contamination inherent in your process, the sterility of your product could be compromised
  • Potential risk factors are, for example, poor plant design, corporate quality culture, human error, errors or lack of control in processes and product controls (not exhaustive)
  • Finally, you have a high risk of delivering contaminated products to the market and, subsequently, being subject to in-depth review by regulatory agencies and customers.

The Service

  • Our service includes performing a proactive and independent assessment by experts in the field. And it should be done before you run into problems!
  • Our risk assessment tool is a well established and effective HAZOP risk assessment method (Hazard Operability Analysis), and has been proven worldwide for 10 years
  • This is a comprehensive review of your production process and the quality of your product, including contamination control systems, QA, QC systems, Media Fill, environmental monitoring, qualification of personnel, training, operator behavior and QA control, aseptic practices, sterilization methods, quality of utilities such as WFI, (non-exhaustive list).
  • Finally, our evaluation, following this in-depth examination (5 days of consultant), results in a simple number and a classification of your risks, called "TRF" (total risk factor), simply indicating the overall risk of your process / product.
  • We will help you prepare the appropriate CAPA and find resolutions for all your problems

Our Methodology

  • Risk assessment is a HAZOP method, which consists of a list of specific questions on each of your production units (currently more than 250 to 300 technical questions)
  • Each technical question is rated on a scale of 1 (excellent) to 5 (very poor or missing) or with 100 when this point has a significant impact
  • The average resulting from all the responses is multiplied by the risk enhancement factor inherent for each production unit, ultimately leading to a total risk factor TRF
  • The lower this number and if in the “low risk / green” range, the process / product will be acceptable with regard to product quality and regulatory compliance
  • Our service includes two tools: sterile APIs and drugs
  • The tool has been used worldwide for 10 years

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