FDA launches QbD pilot programme

Through the programme the FDA is seeking to define the clinically relevant attributes of biologics and link them to the manufacturing process. Volunteer companies are being sought by the agency as it attempts to gain the experience needed to implement a QbD, risk-based approach for complex products and provide clear guidance to the industry. The FDA document states: "The new quality-by-design approach will focus on critical quality attributes related to chemistry, formulation, and process design. ​ ​"Under quality by design, manufacturing will depend on a risk-based approach linking attributes and processes to product performance, safety, and efficacy​." Both original applications and post-approval supplements will make up the programme, which the FDA hopes will include "a variety of pharmaceutical companies and complex biotechnology product types​". Applicants will have to demonstrate increased knowledge of product attributes and link the product to the process parameters detailed in the expanded change protocol. The FDA is looking for applicants to show how they could affect the development of a QbD policy, with multiple unit operations and the stage of product development taken into account for original applications. Participation in the pilot programme is not anticipated to detrimentally affect the FDA's ability to meet the review goal. The agency's intention to establish a QbD approach to pharmaceutical quality is based on its report entitled "Pharmaceutical cGMPs for the 21st Century-A Risk-Based Approach". Experience gained in a pilot programme looking at the sharing of information on QbD for small molecules has also been drawn on in creating the biologics initiative. Many of the same fundamental QbD principles apply to both small molecules and biologics but the complexity of the latter presents a far greater challenge. The biologics pilot programme fits in with the modernization agenda that is underway at the agency as it seeks to equip itself with the tools needed to regulate an increasingly complex global industry. Applicants have until 30 September to apply for the pilot programme. Those wishing to comment on the pilot programme have until 31 December to do so. The FDA document, including details of how to apply for the programme, can be found here​.