The objective of this page is to provide services and news about the implementation of Quality by Design (QbD) and the use of Process Analytical Technologies (PAT) in Pharmaceutical Industrial applications.
Currently, the professionals at Legacy Wyeth (now Pfizer) at Guayama (e.g., Dr. Carlos Conde, Mr. Reinaldo Vazquez, Mr. Ernesto Perez, Ms. Lourdes Lopez, Mr. Hector Garcia, Mr. Vicente Rosado, Mr. Amaury Maldonado, and Mr. Lind Claudio) along with the support from the PAT Core Team including key members from corporate (e.g., Ms. Beth Kendsersky, Dr. TG Venkateshwaran, Dr. Carl Longfellow, Dr. Plinio de los Santos, Dr. Shailesh Singh, Dr. Chunsheng Cai, Dr. Merlin Utter, and Mr. Joseph Bruno) are the leaders in the implementation of QbD-PAT in the Domestic Market. This team received the first approval (April 9, 2010) in which Real Time Release testing was achieved without actually sending samples to the traditional laboratory for release testing.
We all feel very proud of the great team that received this accomplishment. The PAT Core Team also recognizes the contribution from Dr. Dominic Ventura, Dr. Steve Simmons, Dr. Nirdosh Jagota, Dr. Gilberto Quintero, and Dr. Parimal Desai on the required guidance to achieve this accomplishment.