Risk Assessment

Valicare knows the regulatory requirements for quality risk management

 

Quality risk management is a systematic process for the assessment, control, communication and monitoring of quality risks of medicinal products throughout their product life cycle.

Since the introduction of the ICH Q9 guideline in 2006, quality risk management has been a centrally required instrument for maintaining product quality and process stability over time. For this purpose, it is reasonable to implement continuous risk communication and to provide trained decision-maker with the competence to use measures and procedures to ensure quality management.

Valicare GmbH will gladly help you to adapt your existing potential to regulatory requirements, always with a view to your resources and the necessary, appropriate risk management.

We offer training courses and workshops on risk analysis and support you in statistically processing your process data and defining the period for risk management work and procedures. You are thus prepared to write your cyclically required report on your quality risk management.

  • Risk Analysis

    A globally central GMP requirement and an important component of quality risk management is the risk-based consideration of all facilities, procedures and processes used in the production of medicinal products. The EU GMP guidelines are valid for Europe, taking into account ICH Q9 and PIC/S 006. In addition, Annex 11 and GAMP 5 regulate the requirements for IT security. This means that risk assessments must be carried out for your plants, the cleaning procedures, all starting materials, transport, all manufacturing processes and quality control as well as quality assurance procedures, as well as for the computer-based systems and, of course, the specification of the products.

    Our employees have carried out the risk-based qualification and validation of plants and processes in the pharmaceutical industry highly successfully for many years. Therefore, they prepare risk anaylsis successfully on a daily base.

    Based on the complete documentation, we prepare risk analyses using FMEA (Failure Mode and Effects Analysis). All GMP-relevant critical components of the plant and process steps, possible sources of error and their risks are described and critical process steps for product quality and process stability are identified.

    We define necessary steps and actions for qualification and validation and summarize them in a risk analysis report. On request, we conduct a risk analysis workshop based on this report in order to discuss the quality and process-relevant aspects with your respective responsible specialists.

    Of course, other risk-assessment procedures that have been tried and tested by you can also be used, e.g. brainstorming, the Ishikawa diagram or hazard analysis according to Hazard Analysis Critical Control Points (HACCP).

  • Risk-based Specification Definition/Development Control Strategy

    Since 2018, it is discussed, how it could happen that nitrosamines are present in medicines. However, nitrosamines are not the only mutagenic impurities that can result during the production of active ingredients, pharmaceutical excipients and the processing of finished drugs.

    In order to minimize these risks, the current discussion suggests that increasing regulatory requirements will be implemented in the coming years.

    Irrespective, it is already to be expected that in 2021, new versions of the ICH guidelines Q2, Q3D, Q14 and M7 will place increasing demands on the control strategy and quality control of drugs.

    In this context, you should ask yourself the following questions:

    Are your investigations on the impurity profile/contamination level of raw materials up to date?

    Are the process-related risks reflected in the specification of the products?

    Has the risk analysis for possible nitrosamine impurities been prepared and the reporting obligations been implemented?

    If you cannot answer those questions clearly with "Yes", than it is time to act!

    Valicare can support you in complying with these regulatory requirements, which are already mandatory!

    We start with a risk analysis in order to weigh up whether and which critical impurities could have been formed during the process and with the raw material used. If desired, we limit this check to the nitrosamine impurities.

    Based on the results of the risk analysis, the determined impurity profile and the regulatory requirements, we advise and support you in the development of a control strategy to reduce the risk of critical contamination.

    Taking into account the complete product life cycle approach, we propose a suitable specification for your product and develop an efficient test strategy to enable extensive control.

    With this approach, you will meet current and expected increasing regulatory requirements and ensure the quality of your product with regard to critical impurities, especially with nitrosamines.

    More information can be found in the blog article and in the research "Nitrosamines in active ingredients and finished pharmaceuticals".

    If you have any questions about risk-based specification determination, please call us!

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Contact us if you have any questions. We will gladly answer and advise you.

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