Added: May 08, 2008 5:46 pm
The Food and Drug Administration (FDA) intends to solicit proposals for a contractor to fulfill a requirement for FDA's Center for Drug Evaluation and Research for a project entitled Development of Quality by Design (QbD) Guidance Elements on Design Space Specifications Across Scales with Stability Considerations. The NAICS Code is 541712, with a small business size standard 500 employees.
A. Project Background
A goal of FDA's Center for Drug Evaluation and Research is to implement the International Conference on Harmonisation (ICH) guidances Q8, Q9, and Q10 covering drug product development (through Quality by Design), risk management, and quality management systems. The ICH guidances are aligned with CDER's Critical Path initiative, Moving Manufacturing into the 21st Century, to develop new manufacturing approaches that improve sponsors' ability to assess and improve product quality.
Quality by Design (QbD), a component of the ICH Q8 guidance, offers the possibility of improving product quality. Realization of the QbD paradigm requires a systematic framework for determining the design space for specific operations and their processes as a whole. Such a framework will facilitate process innovation and continuous quality improvement, and reduce manufacturing costs. Further the risks of ending up with an undesired and unstable product due to process scale-up have not been addressed systematically. The framework of this study will serve as a basis for formulating best practices and developing science based guidance documents that can be used by industry and potentially FDA to evaluate new and generic drug applications.
B. Statement of Work
To achieve the objectives above, it is necessary for the contractor to evaluate development and manufacturing operations for a small molecule (as opposed to more complex biotech molecules) to:
Implement and/or refine existing models of critical unit operations (mixing and granulation in a high shear mixer, and drying in a fluid bed dryer) to create design spaces and develop process-control-based models to predict and facilitate scale-up of pharmaceutical processes directly from the laboratory or pilot plant to the large commercial scales.
Develop a rigorous methodology with the case study of a small molecule that can be used to generate a preliminary design compatible with the time frame of the development process, and refine the design during and after the commercial scale development.
Understand the factors affecting stability, and evaluate the risk of developing an unstable product because of scale dependent degradation
Develop a peer-reviewed knowledge base to predict real time stability across scales, and transmit the knowledge through development of Knowledge-Based Decision Support Systems.
Develop rationale for expiry dating in a quality by design paradigm.
In addition, the contractor must possess:
Employee Development and Staffing
The contractor shall provide a stable, competent work force to perform each task order. The contractor shall promote among its personnel the importance of gaining insight and appreciation about the organizational structures of CDER/OPS and its mission, policies, and organizational preferences. The contractor shall institute procedures to refresh and enhance this knowledge and understanding. Employees shall remain technically current in their fields of expertise.
Key Personnel
Continuity is critical to successful contract execution. The contractor shall not divert key personnel without the prior written consent of the Project Officer. In the event substitution becomes necessary (e.g., an employee s departure from the company or medical disability), the OPS may require that the contractor provide replacement personnel. The contractor must demonstrate that the prospective substitute personnel possess qualifications commensurate with those of the personnel being replaced. The OPS reserves the right to disapprove the proposed substitutes.
Specialized Expertise
In the performance of this SOW, the contractor may require access to highly specialized management or training skills or industry knowledge that the contractor may not have among its available employee base. Under these circumstances, the contractor may acquire these temporary short-term resources through other means. This contract requires that the contractor have quick and expedient access to these types of specialized business management consulting capabilities.
Necessary Qualifications of Personnel
To successfully fulfill the objectives of this contract, OPS has determined that the following skills or knowledge are essential:
Knowledge of pharmaceutical manufacturing, engineering, and material science
Knowledge of FDA Plain Language guidelines
Demonstrable scientific knowledge by peer-reviewed publications in product/process understanding, Quality by Design by utilizing Process Analytical Technology Control Strategies, and stability research
Federal and Agency Standards and Policy
The contractor shall abide by all FDA and federal regulations, policies, and procedures in effect during the contract period of performance. This includes all changes in laws, regulations, policies, and procedures as they evolve during the contract period of performance.
C. Project Background
A goal of FDA's Center for Drug Evaluation and Research is to implement the International Conference on Harmonisation (ICH) guidances Q8, Q9, and Q10 covering drug product development (through Quality by Design), risk management, and quality management systems. The ICH guidances are aligned with CDER's Critical Path initiative, Moving Manufacturing into the 21st Century, to develop new manufacturing approaches that improve sponsors' ability to assess and improve product quality.
Quality by Design (QbD), a component of the ICH Q8 guidance, offers the possibility of improving product quality. Realization of the QbD paradigm requires a systematic framework for determining the design space for specific operations and their processes as a whole. Such a framework will facilitate process innovation and continuous quality improvement, and reduce manufacturing costs. Further the risks of ending up with an undesired and unstable product due to process scale-up have not been addressed systematically. The framework of this study will serve as a basis for formulating best practices and developing science based guidance documents that can be used by industry and potentially FDA to evaluate new and generic drug applications.
D. Contract Place of Performance
The majority of work under this contract is expected to be conducted at the contractor's site. The laboratory scale work and method validations work will also be conducted collaboratively at FDA laboratories in Silver Spring, Maryland.
E. Additional Information
It is anticipated that a two year contract will be awarded. FDA intends to solicit this requirement as Full and Open competitive requirement. This announcement is not a request for proposal (RFP). FDA anticipates release of the RFP on or around May 26, 2008 and it will be available on the Federal Business Opportunities (FedBizOpps) website. The anticipated award date for this effort is on or before September 1, 2008.
