Quality by Design

The QbD approach needs a profound change in the way of thinking and working, which PTM Consulting realizes by involving the whole organization, using training activities related to know-how and tools, planning, and realizing an integrated flexible network for shared information.

PTM PRODUCT & PROCESS OPTIMIZATION (P&PO) service supports customers from the early stages of product development, from the laboratory to the pilot phase to the industrial phase, ensuring the excellence in  quality, time and cost reduction through implementation of the principles of Quality by Design.

The principles of QbD

The International Conference on Harmonization (ICH)  translated Quality by Design (QbD) principles into some guidelines such as ICH Q8 (R2) “Pharmaceutical Development”, ICH Q9 “Quality Risk Management” and ICH Q10 “Pharmaceutical Quality System” defined as:

 “A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.” (ICH Q8 (R2) – Pharmaceutical Development, 2009).

The QbD, a fundamental set of guidelines for the pharmaceutical industry of the new millennium, requires a change in the way of working, designing and conceiving the quality of drugs  from the early stages of development: “Quality can not be tested in products; ie, quality should be built in by design “.

From “ simple” development to quality compliant development

PTM Consulting services, built on  quality paradigms introduced by the ICH Q8, constantly applies  QbD systemic philosophy to achieve quality objectives and defined cost thanks to  thorough understanding of the product, the production process and mainly the development process.

Product  and process tangible results

The working principles of QbD framework PTM used in various  projects, allows to achieve three fundamental goals:

  1. increase the understanding of the product and its production process;
  2. Increase product and process robustness;
  3. use scientific methods.

Validation, Quality and Manufacturing Support

Product and process optimization, made through P&PO implementation, can be  achieved through the use of risk analysis tools and statistical techniques to support Validation, Quality and Manufacturing activities.