Integrated planning requires a team with a leader whose sole accountability is for the total success of the new product from defining the opportunity through customer purchase, use, service, and recommendation to others.
[9] In addition to organizational integration, a successful team must begin with clearly articulated common goals for the product that are measurable and authorized by the enterprise.
The structure is the common framework for all participants in launching the new product and helps ensure success.
[7] Quality by design offers a range of tools and methods intended to make these tradeoffs explicit and optimal for the customer.
[7] The FDA imperative is outlined in its report "Pharmaceutical Quality for the 21st Century: A Risk-Based Approach.
FDA's release of the Process Validation[12] guidance in January 2011 notes the need for companies to continue benefiting from knowledge gained, and continually improve throughout the process lifecycle by making adaptations to assure root causes of manufacturing problems are corrected.
The ICH Guidelines Q8 through Q11 encapsulate these unified recommendations and provide some assistance for manufacturers to implement quality by design into their own operations.
ICH Guideline Q8 describes QbD-based drug formulation development and was first published in 2004, being subsequently revised in 2008 (Q8(R2)).