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October 02, 2006
Whether you advance your technology from concept to commercialization or use a third party for parts or all of this work, the ability to do technology transfer flawlessly is essential to successful, efficient pharmaceutical production.
Getting "swamped at work" takes on an entirely new meaning for these GMP Agents.
October 01, 2006
Developed in the 1950s as a means to survive and compete against the giants of the automotive sector, lean manufacturing helped Toyota evolve from a small-volume producer (with little capital) to become a high-volume manufacturer in a process-rich environment. Toyota achieved this by using developments such as total production maintenance (TPM), just-in-time (JIT), Kanban, value stream mapping and Kaizen events.1 A summary of some of the lean terminology is shown in Table 1.
September 12, 2006
Washington, DC (Sept. 12)-The Office of New Drug Quality Assessment (ONDQA) in the Center for Drug Evaluation and Research (CDER) has approved one new drug application (NDA) under its CMC Pilot Program and has two more applications are under review. The pilot was established last year to provide an opportunity for FDA and industry to explore strategies for including Quality by Design (QbD) principles and process analytical technology approaches in regulatory submissions, explained ONDQA deputy director Chi-wan Chen at the PDA-FDA Joint Regulatory Conference here
September 07, 2006
Washington, DC (Sept. 1) - In a Federal Register announcement the US Food and Drug Administration laid out its guidance agenda for the coming months.
Arthur R. Mlodozeniec, PhD, a member of Pharmaceutical Technology's advisory board and past president of AAPS, died on Sept. 4.
September 02, 2006
As the pace of product development accelerates, the approach to dissolution-method development must advance beyond a manual method and an assay. A natural progression of the method-development process must include the transfer of the manual method onto automated instrumentation.
Apparently, the inspector would sneak off to visit his relatives on FDA time, instead of visiting us.
August 02, 2006
Thanks to you, we have this month's column. Keep those cards, letters, and e-mails coming.
July 02, 2006
This article summarizes changes to the Akers–Agalloco aseptic processing risk analysis model (first presented in Pharmaceutical Technology's November 2005 issue) as well as some of the underlying thinking behind the revision. The simplified model makes the method easier to use because of its greater flexibility of environmental control practice. It maintains the emphasis on human activity as the primary consideration in risk management for aseptic processing.