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Diane Paskiet, Director, Scientific Affairs, will present at two sessions during the 2012 PDA Annual Meeting. The meeting will be held from April 16-18, 2012 at the JW Marriott Desert Ridge Resort in Phoenix, Arizona.
On Tuesday, Diane will present “PQRI Activities: Influence on Best Practices in NA and Europe” on Tuesday, April 17 from 4:00-5:30.” Diane will also present “Drug Product Contact Materials: Stage Appropriate Assessments for Quality Performance,” on Wednesday from 9:00-9:30 a.m.
The Wednesday session will discuss how modern GMP expectations are transforming the way drug products are being developed, manufactured, evaluated and controlled. The movement from ascertaining product quality predominantly by end product testing to achieving quality by design of effective and efficient manufacturing processes is reinventing the GMP landscape. Drug product formulation development summaries should highlight the evolution from initial concept up to the final design and take into consideration the choice of drug product container closure systems (ICHQ8). While the design features are dependent on the user needs, the selection of contact materials including the fabrication, assembly and filling is contingent on the characteristics of the drug product formulation.
During drug product development multiple changes in manufacturing will likely take place and the contact materials used in development, scale up and commercialization should be qualified for use. The level of evaluation should be appropriate and proportionate to the drug product stage goals. Principles of quality risk management can be applied to assess the materials in contact with drug products through-out the lifecycle. Identification and justification of these key materials and parameters will support drug product safety and efficacy. This presentation will examine critical parameters to be evaluated with regard to primary container/delivery systems recognizing the needs for different stages of the drug product lifecycle.
The 2012 PDA Annual Meeting focuses on science and technology innovation as well as optimized performance, offering extensive formal and informal networking opportunities and providing a forum to contribute to and influence the advancement of science and regulation in the pharmaceutical and biopharmaceutical industry. This year’s theme centers on Manufacturing Innovation: Achieving Excellence in Sterile and Emerging Biopharmaceutical Technology.
For more information or to register to attend, visit http://pdaannualmeeting.org.
It can take more than 12 years and a major financial investment to bring a drug product to market.<sup>1</sup> A drug product’s success relies on its efficacy, safety and manufacturing efficiencies along with the use of innovative strategies to meet evolving market needs and reinforcement of patient adherence. The importance of container closure and delivery systems as critical to success in the pharmaceutical industry is becoming more visible especially in respect to pharmaceutical and biotech organizations that desire to proactively minimize their risks.
In recent years, there has been a shift in the pharmaceutical industry toward a Quality by Design (QbD) philosophy. To maximize a drug product’s safety and efficacy, pharmaceutical companies and their drug packaging and delivery partners are building new quality principles into the entire manufacturing process, from design and development to commercialization and administration. This scientific, risk-based QbD approach is fast becoming an essential strategy for bringing high-quality therapeutics to market quickly and efficiently.
Fran DeGrazio is an industry leader with over 35 years of experience in technical product development, quality, regulatory, marketing, and business strategy. Prior to retirement in 2022, DeGrazio was West Pharmaceutical Services’ Chief Scientific Officer and led a legacy of innovation through Quality by Design (QbD) and leading patient-centric elastomer components. Before her retirement I had the opportunity to discuss the development of 4040/40 gray formulation as the newest addition to West’s quality by design program the formula journey, the evolution and its importance in the marketplace.
The current pharmaceutical market has faced a variety of challenges, including increasing expectations for quality from end-users and regulatory agencies driven by concern for patient safety. While pharmaceutical companies are working to assure that new quality and compliance paradigms are met, a balance must be achieved between the reality of managing costs to provide a product that meets payer’s requirements and facilitating profitability in order to continue adequate business reinvestment.
Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission. Defined as extractables and leachables, these assessments continue to evolve and expand due to consistently increasing regulatory agency expectations. Agency expectations require you to act sooner rather than later. Waiting until Phase III in drug development can lead to delays and additional costs due to poor assessments that are questioned by the reviewer, or incomplete submissions that require you to redo or execute additional work. You can start your Extractables and Leachables (E&L) assessment as soon as you have selected your packaging components.
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