Valicare knows the regulatory requirements for quality risk management
"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.
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.
Risk analysis is the most prominent tool of risk management. It is the most unique formal method to define the scope of security measures leading to risk acceptance in pharmaceutical industry. Therefore, it is regularly exercised for every equipment, utility or hardware system and to all processes performed.
The consultant team of Valicare GmbH has been executed risk-based qualification and validation in pharmaceutical industry successfully for 15 years. Established tools and documents are proven by hundreds of audits and inspections. Valicare experts are well-experienced also with customer specific equipment and specialized processes.
Based on detailed technical documentation we apply the Failure Mode and Effects Analysis (FMEA), the method classically used for objective risk quantification. Thereby, all GMP-relevant components and process steps are covered, risks are discussed and critical quality process parameters are defined and evaluated.
Consequently necessary steps and measures for the qualification and validation activities are defined thus achieving a level of risk acceptance according international GMP requirements. Results are documented in a formal risk analysis report. On customers demand documentation will be discussed intensively in a workshop together with internal experts for the integration of valuable customer expertise.
Besides the FMEA method Valicare´s experts are also very familiar with and able to handle other procedures often applied in pharmaceutical industry, e.g. Fishbone Diagram, Fault Tree Analysis (FTA) or Hazard Analysis and Critical Control Points (HACCP).