SUNNYVALE, Calif., Aug. 30 /PRNewswire/ -- Conformia, one of the FDA's Cooperative Research and Development Agreement (CRADA) Partners, joined forces with the Food and Drug Administration (FDA) on August 23, 2007, in a presentation focusing on the FDA's Quality by Design (QbD) initiative at the Third Annual Regulatory and Compliance Symposium -- "Managing Risks -- From Pipeline to Patient." The symposium was held at Harvard University.
Helen Winkle, Director of the Office of Pharmaceutical Sciences, a part of the Center for Drug Evaluation and Research, shared the progress the FDA is making, as well as the challenges that both the FDA and the industry face in moving to the "desired state." Winkle pointed out that Chemistry Manufacturing and Controls (CMC) requirements are part of the critical path both within the FDA and within industry, and described how the Quality by Design (QbD) initiative is created to help reduce excessive regulatory burden and provide mechanisms for regulatory flexibility.
Anjali Kataria, principal investigator of the FDA-Conformia Cooperative Research and Development Agreement (CRADA) study, presented research from the CRADA study of nine blinded pharmaceutical / biotech companies. She highlighted results including the bottlenecks and obstacles companies face in implementing QbD, as well as the top priorities study companies articulated -- such as gaining more assurance from the FDA that reviewers, inspectors and policy makers are all being trained to support the "desired state."
Winkle and Kataria presented both findings and actions resulting from part one of the Conformia CRADA study that queried pharmaceutical and biotech leaders about meeting the goals of the FDA's QbD initiative. The preliminary findings led to an expanded CRADA study and a series of first-of-a-kind Conformia-FDA-PhRMA trainings for cross-functional pharmaceutical leadership teams.
The Harvard presentation focused on:
-- The state of pharmaceutical manufacturing
-- Consequences pharmaceutical companies face in the present environment
-- The current state of the regulatory quality review process
-- The mutual goal for industry, society and regulators to reliably
produce high-quality products without extensive regulatory oversight
-- Benefits of the new QbD paradigm for both the FDA and the industry
About the CRADA Study
The CRADA study began in April 2006 as a preliminary study of nine companies and is due to expand to 25 companies. Focusing on understanding the current practices of pharmaceutical development and commercialization, the study is designed to align with the FDA's Current Good Manufacturing Practice (cGMP) initiative for the 21st century and the Critical Path initiative, of which QbD is a key component. The study is unique because it enables companies to openly share their concerns with the FDA without fear of ramifications.
The presentation is available on the Conformia website -- http://www.conformia.com
Conformia is the market leader and innovator in product/process lifecycle management (PPLM) software solutions for regulated process industries including life sciences and beverage alcohol. These solutions enable pharmaceutical companies to save significant time and money through major improvements in product/process development operations by creating central master active pharmaceutical ingredients and formulation databases across the lifecycle. Conformia's web-based enterprise software helps improve product quality, provides a platform for regulatory flexibility, decreases time to market, increases product / process operational effectiveness and streamlines tech transfer. Conformia is offered as an SAP-endorsed business solution for pharmaceutical development operations and beverage alcohol operations. Together SAP and Conformia are building a bridge to support the product/process lifecycle from development to manufacturing thereby enabling companies to achieve Quality by Design across the lifecycle. For more information, go to http://www.conformia.com.
Conformia is a registered trademark of Conformia Software Inc. All other brands, products, or service names are or may be trademarks or service marks of their respective owners.
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