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Preparation of New Drug Application (NDA)/Abbreviated New Drug Application (ANDA) Major and Moderate Post-Approval Changes for Parental Drug Products Site Transfer
(Polytechnic University of Puerto Rico, 2010)
Actually, the Food and Drug Administration is the United States Federal Agency responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products ...
Design of an Environmental Monitoring Program for a New Biotechnology Facility
(Polytechnic University of Puerto Rico, 2010)
A new biotechnology facility in Puerto Rico is in need of an Environmental Program to ensure the stability of room conditions for the manufacturing of their products. This environmental baseline study provided documented ...
Lean and Safe Manufacturing for an Antidepressant Tablets Coating Process
(Polytechnic University of Puerto Rico, 2010)
The Lean and Safe Manufacturing Process (6S event0 was selected for implementation in an antidepressant tablets coating manufacturing process. The coating process was identified due to the utilization of toxic ingredients ...