The objective of this study is to unify understanding of the concepts of Operational Excellence and Process Evaluation in non-sterile solid dosage form manufacturing and to identify the potential cause of problems. It is becoming widely recognized in the pharmaceutical industry that a more structured approach to process development would benefit the quality of the […]
The objective of this study is to unify understanding of the current concepts of process robustness and application of robustness principles to non-sterile solid dosage form manufacturing. Process robustness activities start at the earliest stages of process design and continue throughout the life of the product, it suggests greater process certainty in terms of yields, […]
Validation is an integral part of quality assurance; it involves systematic study of systems, facilities and processes aimed at determining whether they perform their intended functions adequately and consistently as specified. Validation in itself does not improve processes but confirms that the processes have been properly developed and are under control. Adequate validation is beneficial […]
Once upon a time, a company decided to improve their packaging sealing process. They selected equipment with a new technology that would process more products in less time with improved seal characteristics. The equipment was specified and approved. A qualification project team was formed and prepared a validation project plan that described how the revised […]
The Water generation and distribution system has very high importance in Pharmaceuticals and it becomes very critical when it is a injectable unit. The qualification procedure of the water generation and distribution system is well described in the various guidelines. The water system is qualified through the various Phases Phase I, Phase II and Phase […]
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