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:
- increase the understanding of the product and its production process;
- Increase product and process robustness;
- use scientific methods.
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.