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FDA Regulatory Compliance Advisors, Inc.

Is intended to assist Industry in the process of communicating QbD information and conclusions to international regulatory authorities, including FDA. This guidance describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format.

The Guidance for Industry ICH Q8, Pharmaceutical Development: 

Quality by Design is a scientific, risk-based, holistic and proactive approach to pharmaceutical development, and consists of a deliberate design effort from product conception through commercialization that results in a full understanding of how product attributes and process relate to product performance. 

To realize this flexibility, the applicant should demonstrate an enhanced knowledge of product performance over a range of material attributes, manufacturing process options and process parameters. The application of formal experimental designs, process analytical technology (PAT), and/or prior knowledge can help gain this understanding.

The degree of regulatory flexibility is predicated on the level of relevant scientific knowledge provided. 

"The Key to Process Understanding"

Quality by


  • risk-based regulatory decisions (reviews and inspections)
  • manufacturing process improvements, within the approved design space described in the dossier, without further regulatory review
  • reduction of post-approval submissions
  • real-time quality control, leading to a reduction of end-product release testing

Because of her training and experience conducting pre-operational reviews and pre-approval inspections of QbD and PAT applications, Rebeca Rodríguez,  Former FDA National Expert Investigator / FDA National Lead Instructor and President FDA-RCA™, has a thorough understanding of the technical and regulatory tools that will help your company effectively implement QbD and successfully demonstrate to FDA an enhanced level of process understanding that can result in regulatory flexibility.  

Ultimately, QbD can also help foster innovation in your company and gain a leading edge over competitors while increasing the efficiency of your manufacturing processes and the quality of your products. 

The Pharmaceutical Development section is intended to provide a comprehensive understanding of the product and manufacturing process for reviewers and inspectors. The guidance also indicates areas where the demonstration of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches, for example, to facilitate: