Integrated Quality Risk Management

PTM Consulting applies QRM for the assessment, control, communication and review of risks to the quality of the drug product across the product lifecycle

PTM Consulting has always been known for its risk management approach methodology as a fundamental theorical base for every activity . PTM, with the INTEGRATED QUALITY RISK MANAGEMENT service has transformed the concept of QRM from a simple operational tool to a  strategic tool to support decision-making processes.

quality-risk-management-2The beginning: 15 years of ICH Q9

Starting in early 2011, Good Manufacturing Practices (GMP) Annex 20, known as ICH Q9 – Quality Risk Management, has been included as part of GMPs becoming the central chapter of Part II.

This step started  a real evolution reflecting the increasing importance that Quality Risk Management (QRM) achieved over the years within pharmaceutical companies as a systematic process to evaluate, control and communicate the risks associated with quality of the product.

PTM Consulting has been able to accompany companies in applying QRM and transforming the concept of risk into a daily tool to ensure quality.

QRM integrated into the company system

Starting from timely applications, Quality Risk Management (QRM) has gradually taken on an increasingly integrated character. QRM has become a reality within companies to identify product and / or process risks; Ptm innovation department is creating  new organizational and strategic tools suitable to expand  QRM concepts also in other business areas.

The long experience PTM developed during many projects in this area reinforce the idea of ​​QRM as a tool very useful at different levels and business contexts, from product development to optimization of a production platform and more generally for effective management and communication information.

Single QRM applications can be seen as important operational steps, part of a top-level project management that ends up integrating with the entire portfolio of business projects, thus changing the focus of QRM from operational to strategic.

 Our  approach: a holistic approach

The PTM approach to Risk Management is HOLISTIC:  a risk management strategy is formulated for every aspect quality, development, production, including all the different levels of the company. With systemic methodologies PTM helps companies define and share key risk management information throughout the entire product life cycle from research and development to production.

From operational tool to strategic tool

The possible, different  applications of QRM, developed by PTM in numerous projects, show its flexibility and  its innovative role within companies: QRM can be used not only as a tool for product / process optimization, but also as an integrated decision-making tool for product portfolio management in accordance with the company’s strategy.