Original Articles
Lavudi Saida and P. Chaitanya
Abstract
Process validation is a requirement of the current good manufacturing practices (cGMP) regulations for finished pharmaceuticals. Validation is defined as a documented program that provides a high degree of assurance that a specific process, method or system will constantly produce a result meeting pre-determined acceptance criteria. In this study formulation and development of capsules containing drug Duloxetine Anti-depressant drug belongs to Class-II Bio pharmaceutics Classification. Coating was done using sugar spheres and these pellets were filled in capsules. Validation of process for formulation of Duloxetine hydrochloride capsules were done. The objectives of this study were determine critical process parameters for coating and capsule filling operation, to establish boundary limits for critical process parameters which influence the product, process quality and performance and to evaluate coated pellets and filled capsules. This paper deals with the Process performance qualification of Duloxetine hydrochloride capsules 60mg, 30mg.During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing. Validation study will be initiated on 3 batches. During this study the process design will be evaluated to determine its capability to manufacture reproducible commercial batches of Duloxetine hydrochloride capsules 60mg, 30mg.The process understanding and process knowledge gained from the product developmental study, exhibit batch and process evaluation studies in the commercial batches will be leveraged. Data shall be generated during this study is used to establish documented evidence that the process is capable of manufacturing reproducible commercial batches and consistently deliver quality product.