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.

Quality by Design

Quality by Design (QbD) is a systematic approach that start with predefined objectives, emphasizes product and process understanding and control, by improving drug product development, minimizing costs and resources.

Pharma industries normally considered product quality as the compliance with specifications and regulatory guidelines, with a consequential increase of time, costs and difficulties in product development and production.

The shift from “compliance” to Quality by Design has yielded modernization of product quality.

The International Conference on Harmonization (ICH) has transcribed the principles of QbD in guidelines such as ICH Q8 (R1) “Pharmaceutical Development”, ICH Q9 “Quality Risk Management” and ICH Q10 “Pharmaceutical Quality System”.

The core concept is that “Quality cannot be tested in products, i.e. quality should be built in by design”.

QbD identifies attributes of materials and components, till to process parameters that can influence the quality of the drug product.

Quality by Design approach

PTM Consulting applies the Quality by Design approach which includes the following stages:

  1. Defining the Quality Target Product Profile (QTPP)
  2. Identifying potential Critical Quality Attributes
  3. Determining the Critical Quality Attributes of the drug substance
  4. Selecting an appropriate manufacturing process
  5. Defining the Adequate Control Strategy

Quality by Design benefits and advantages

  • Ensures better design of products with fewer problems in manufacturing
  • Reduces number of manufacturing supplements required for post market changes, relying on process and risk understanding, and risk mitigation;
  • Allows implementation of new technology to improve manufacturing reducing regulatory impact
  • Reduce overall costs of manufacturing (less waste)
  • Ensures less “hassle” during review, reducing deficiencies and allowing quicker approvals;
  • Improves interaction with FDA, leading to discussions on a scientific level instead of on a process level;
  • Allows continuous improvement in products and manufacturing processes;
  • Allows for better understanding of how APIs and excipients affect manufacturing
  • Relates manufacturing to clinical during design
  • Provides a better overall business model

PTM Consulting and Quality by Design:

PTM Consulting supports the realization and implementation of new manufacturing platforms leading to advantages for:

  • Manufacturers – less regulatory burden and enhanced efficiency/efficacy;
  • Regulators – lighter regulatory burden and higher assurance of product quality;
  • Patients – availability of life saving medicines and higher assurance of product quality