Risk Management and Risk Analysis

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    Risk management and risk analysis

    "Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle", ICH Q9, Nov. 2005.

    Call +49 69 7909 343 for support.

  • next page

    Risk management and risk analysis

    "Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle", ICH Q9, Nov. 2005.

    Call +49 69 7909 343 for support.

  • next page

    Risk management and risk analysis

    "Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle", ICH Q9, Nov. 2005.

    Call +49 69 7909 343 for support.

 
Content

Valicare knows the regulatory requirements for quality risk management

A worldwide harmonized central GMP requirement and also one of the most important tools of quality management in pharmaceutical industry is the so-called risk-based approach. It was formally introduced by the FDA in 2004. Hence risk management is part of the pharmaceutical quality system and risk analysis is a central tool to evaluate risks in the lifecycle of a pharmaceutical product.

The topic leading document in Europe is the EU GMP guideline with the ICH Q9 guidance in Part III. This document provides the general binding description of risk management and prescribes risk evaluation as a binding subject for facilities, installations and processes used to manufacture pharmaceutical products.

In addition, annex 11 regulates the requirements for IT-systems and the GAMP 5 guideline is usually applied for IT-system validation although it is a non-binding document.

Valicare GmbH is experienced in setting up risk management systems either in case of start-ups from scratch or in integrating established tools in a running quality system towards a holistic and successful management of risk in a pharmaceutical enterprise.

Our consultant team provides support on the basis of pre-established risk management concepts and solutions that can be customized to fit into your company environment. We will analyze your current situation, discuss necessary risk management updates and help you during implementation and execution of those additional measures. At the end we generate a final risk management implementation and operation report, which can be redone every year to amend your company´s management review.