Director, Scientific Affairs
April 03, 2012
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.