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Papers by german Fernandez Otero
Determination of Bile Acids In Pharmaceutical Dosage Forms By Hplc
Analytical Letters, 1989
ABSTRACT
Journal of High Resolution Chromatography, 1996
Practical Application of Quality Risk Management to the Filling Process of Betamethasone Injections
Pharmaceutical Engineering
In the last years, the pharmaceutical industry has begun to incorporate the new paradigm promoted... more In the last years, the pharmaceutical industry has begun to incorporate the new paradigm promoted by the FDA through the Risk Management/QbD approach: “Quality cannot be tested into products; it should be built-in or should be by design”. To ensure that quality is built into the pharmaceutical products, the most up-to-date technologies and concepts of risk management should be incorporated into the manufacturing process. As part of this new approach, the present work studies and evaluates the filling process of Betamethasone Injection in order to reduce its associated risks, where risk is understood as “the combination of the probability of occurrence of harm and the severity of that harm”. Is the aim of the present work to illustrate the application of different Risk Management tools and the permeability of the local pharmaceutical industry to these ideas.
Determination of Bile Acids In Pharmaceutical Dosage Forms By Hplc
Analytical Letters, 1989
ABSTRACT
Journal of High Resolution Chromatography, 1996
Practical Application of Quality Risk Management to the Filling Process of Betamethasone Injections
Pharmaceutical Engineering
In the last years, the pharmaceutical industry has begun to incorporate the new paradigm promoted... more In the last years, the pharmaceutical industry has begun to incorporate the new paradigm promoted by the FDA through the Risk Management/QbD approach: “Quality cannot be tested into products; it should be built-in or should be by design”. To ensure that quality is built into the pharmaceutical products, the most up-to-date technologies and concepts of risk management should be incorporated into the manufacturing process. As part of this new approach, the present work studies and evaluates the filling process of Betamethasone Injection in order to reduce its associated risks, where risk is understood as “the combination of the probability of occurrence of harm and the severity of that harm”. Is the aim of the present work to illustrate the application of different Risk Management tools and the permeability of the local pharmaceutical industry to these ideas.